Protocol Index	

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OP RESEARCH PRO00038342 / ALE1001 SHAH PHASE 2	

Types:      Research Oncology Treatment
Synonyms:  LEUKEMIA

Cycle 1	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    75276617ALE1001_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Dose Modifications and Management for  Treatment Bleximenib : Refer to Section 6.5 Protocol Access Hyperlink:   75276617ALE1001_Shah
			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Eligibility criteria
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Performance status:  Refer to Section 5.1 and Section 10.16 or Oken 1982 for age appropriate application.
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Complete Physical examination
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Patient-reported outcomes
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Patient-reported outcomes
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs:  Temperature, heart rate, and blood pressure. Refer to Section 8.2.3.
			Procedures
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	12-lead ECG:  12-lead triplicate ECGs (ie, 3 individual ECG tracings) will be performed at the timepoints indicated. When ECGs and PK samples occur at the same time point, ECGs should be collected first followed by the PK sample in the specified time window. ECG sampling may be adjusted by the Sponsor and/or SET based on emerging data.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	PK Samples:  Plasma, refer to Table 5 for Cohort-specific sampling requirements
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	GGT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	LDH	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CHOLESTEROL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	FERRITIN LEVEL	Interval: --	Occurrences: --		  	TRIGLYCERIDES	Interval: --	Occurrences: --			Labs
  	PT AND PTT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		  	D-DIMER	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Refer to Section 8.2.6 and Section 10.2. Women of childbearing potential must have a negative highly sensitive serum (B-human chorionic gonadotropin) at screening and again within 48 hours prior to the first dose of study treatment. A urine or serum test is acceptable at subsequent time points.
			Medications
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 50mg twice daily on days 1-14 of cycle 1 for oral dosing.
			Provider Communication
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 50mg twice daily on days 1-14 of cycle 1 for oral dosing.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib accountability:  In addition to drug accountability, monitor compliance on an ongoing basis per institutional standards. Refer to Sections 6.2 and 6.3.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study drug will be administered in the clinic on the days that PK samples are obtained (PK samples and Study drug will be administered on C1D1, C1D15, C2D1)
				Day 4	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    75276617ALE1001_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Dose Modifications and Management for  Treatment Bleximenib : Refer to Section 6.5 Protocol Access Hyperlink:   75276617ALE1001_Shah
			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs:  Temperature, heart rate, and blood pressure. Refer to Section 8.2.3.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	GGT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	LDH	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CHOLESTEROL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	FERRITIN LEVEL	Interval: --	Occurrences: --		  	TRIGLYCERIDES	Interval: --	Occurrences: --			Medications
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 50mg twice daily on days 1-14 of cycle 1 for oral dosing.
			Provider Communication
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 50mg twice daily on days 1-14 of cycle 1 for oral dosing.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib accountability:  In addition to drug accountability, monitor compliance on an ongoing basis per institutional standards. Refer to Sections 6.2 and 6.3.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study drug will be administered in the clinic on the days that PK samples are obtained (PK samples and Study drug will be administered on C1D1, C1D15, C2D1)
				Day 8	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    75276617ALE1001_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Dose Modifications and Management for  Treatment Bleximenib : Refer to Section 6.5 Protocol Access Hyperlink:   75276617ALE1001_Shah
			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Performance status:  Refer to Section 5.1 and Section 10.16 or Oken 1982 for age appropriate application.
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs:  Temperature, heart rate, and blood pressure. Refer to Section 8.2.3.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	GGT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	LDH	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CHOLESTEROL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	FERRITIN LEVEL	Interval: --	Occurrences: --		  	TRIGLYCERIDES	Interval: --	Occurrences: --			Labs
  	PT AND PTT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		  	D-DIMER	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Medications
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 50mg twice daily on days 1-14 of cycle 1 for oral dosing.
			Provider Communication
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 50mg twice daily on days 1-14 of cycle 1 for oral dosing.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib accountability:  In addition to drug accountability, monitor compliance on an ongoing basis per institutional standards. Refer to Sections 6.2 and 6.3.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study drug will be administered in the clinic on the days that PK samples are obtained (PK samples and Study drug will be administered on C1D1, C1D15, C2D1)
				Day 15	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    75276617ALE1001_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Dose Modifications and Management for  Treatment Bleximenib : Refer to Section 6.5 Protocol Access Hyperlink:   75276617ALE1001_Shah
			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Performance status:  Refer to Section 5.1 and Section 10.16 or Oken 1982 for age appropriate application.
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs:  Temperature, heart rate, and blood pressure. Refer to Section 8.2.3.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	PK Samples:  Plasma, refer to Table 5 for Cohort-specific sampling requirements
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	GGT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	LDH	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CHOLESTEROL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	FERRITIN LEVEL	Interval: --	Occurrences: --		  	TRIGLYCERIDES	Interval: --	Occurrences: --			Labs
  	PT AND PTT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		  	D-DIMER	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Medications
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Provider Communication
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib accountability:  In addition to drug accountability, monitor compliance on an ongoing basis per institutional standards. Refer to Sections 6.2 and 6.3.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study drug will be administered in the clinic on the days that PK samples are obtained (PK samples and Study drug will be administered on C1D1, C1D15, C2D1)
				Day 18	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    75276617ALE1001_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Dose Modifications and Management for  Treatment Bleximenib : Refer to Section 6.5 Protocol Access Hyperlink:   75276617ALE1001_Shah
			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Performance status:  Refer to Section 5.1 and Section 10.16 or Oken 1982 for age appropriate application.
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs:  Temperature, heart rate, and blood pressure. Refer to Section 8.2.3.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	PK Samples:  Plasma, refer to Table 5 for Cohort-specific sampling requirements
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	GGT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	LDH	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CHOLESTEROL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	FERRITIN LEVEL	Interval: --	Occurrences: --		  	TRIGLYCERIDES	Interval: --	Occurrences: --			Medications
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Provider Communication
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib accountability:  In addition to drug accountability, monitor compliance on an ongoing basis per institutional standards. Refer to Sections 6.2 and 6.3.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study drug will be administered in the clinic on the days that PK samples are obtained (PK samples and Study drug will be administered on C1D1, C1D15, C2D1)
				Day 22	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    75276617ALE1001_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Dose Modifications and Management for  Treatment Bleximenib : Refer to Section 6.5 Protocol Access Hyperlink:   75276617ALE1001_Shah
			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Performance status:  Refer to Section 5.1 and Section 10.16 or Oken 1982 for age appropriate application.
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs:  Temperature, heart rate, and blood pressure. Refer to Section 8.2.3.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	GGT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	LDH	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CHOLESTEROL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	FERRITIN LEVEL	Interval: --	Occurrences: --		  	TRIGLYCERIDES	Interval: --	Occurrences: --			Medications
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Provider Communication
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib accountability:  In addition to drug accountability, monitor compliance on an ongoing basis per institutional standards. Refer to Sections 6.2 and 6.3.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study drug will be administered in the clinic on the days that PK samples are obtained (PK samples and Study drug will be administered on C1D1, C1D15, C2D1)
					
Cycle 2	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    75276617ALE1001_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Dose Modifications and Management for  Treatment Bleximenib : Refer to Section 6.5 Protocol Access Hyperlink:   75276617ALE1001_Shah
			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Performance status:  Refer to Section 5.1 and Section 10.16 or Oken 1982 for age appropriate application.
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Complete Physical examination
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Patient-reported outcomes
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Patient-reported outcomes
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs:  Temperature, heart rate, and blood pressure. Refer to Section 8.2.3.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	PK Samples:  Plasma, refer to Table 5 for Cohort-specific sampling requirements
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	BM aspirate:  DE Sampling Timepoints (±3D): C2D1; C3D1; C5D1; C7D1; then every 3 cycles (±1 week); EOT; and as clinically indicated.  Local CBCs (including circulating blasts) are drawn at the time of DE (±3d) and <=14 days after DE for response assessment
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood:  DE Sampling Timepoints (±3D): C2D1; C3D1; C5D1; C7D1; then every 3 cycles (±1 week); EOT; and as clinically indicated.  Local CBCs (including circulating blasts) are drawn at the time of DE (±3d) and <=14 days after DE for response assessment
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	GGT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	LDH	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CHOLESTEROL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	FERRITIN LEVEL	Interval: --	Occurrences: --		  	TRIGLYCERIDES	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Medications
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Provider Communication
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib accountability:  In addition to drug accountability, monitor compliance on an ongoing basis per institutional standards. Refer to Sections 6.2 and 6.3.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study drug will be administered in the clinic on the days that PK samples are obtained (PK samples and Study drug will be administered on C1D1, C1D15, C2D1)
					
Cycle 3	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    75276617ALE1001_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Dose Modifications and Management for  Treatment Bleximenib : Refer to Section 6.5 Protocol Access Hyperlink:   75276617ALE1001_Shah
			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Performance status:  Refer to Section 5.1 and Section 10.16 or Oken 1982 for age appropriate application.
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Complete Physical examination
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Patient-reported outcomes
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Patient-reported outcomes
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs:  Temperature, heart rate, and blood pressure. Refer to Section 8.2.3.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	BM aspirate:  DE Sampling Timepoints (±3D): C2D1; C3D1; C5D1; C7D1; then every 3 cycles (±1 week); EOT; and as clinically indicated.  Local CBCs (including circulating blasts) are drawn at the time of DE (±3d) and <=14 days after DE for response assessment
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood:  DE Sampling Timepoints (±3D): C2D1; C3D1; C5D1; C7D1; then every 3 cycles (±1 week); EOT; and as clinically indicated.  Local CBCs (including circulating blasts) are drawn at the time of DE (±3d) and <=14 days after DE for response assessment
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	GGT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	LDH	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CHOLESTEROL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Medications
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Provider Communication
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib accountability:  In addition to drug accountability, monitor compliance on an ongoing basis per institutional standards. Refer to Sections 6.2 and 6.3.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study drug will be administered in the clinic on the days that PK samples are obtained (PK samples and Study drug will be administered on C1D1, C1D15, C2D1)
					
Cycle 4	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    75276617ALE1001_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Dose Modifications and Management for  Treatment Bleximenib : Refer to Section 6.5 Protocol Access Hyperlink:   75276617ALE1001_Shah
			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Performance status:  Refer to Section 5.1 and Section 10.16 or Oken 1982 for age appropriate application.
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs:  Temperature, heart rate, and blood pressure. Refer to Section 8.2.3.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	BM aspirate:  DE Sampling Timepoints (±3D): C2D1; C3D1; C5D1; C7D1; then every 3 cycles (±1 week); EOT; and as clinically indicated.  Local CBCs (including circulating blasts) are drawn at the time of DE (±3d) and <=14 days after DE for response assessment
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	GGT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	LDH	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CHOLESTEROL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Medications
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Provider Communication
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib accountability:  In addition to drug accountability, monitor compliance on an ongoing basis per institutional standards. Refer to Sections 6.2 and 6.3.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study drug will be administered in the clinic on the days that PK samples are obtained (PK samples and Study drug will be administered on C1D1, C1D15, C2D1)
					
Cycle 5	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    75276617ALE1001_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Dose Modifications and Management for  Treatment Bleximenib : Refer to Section 6.5 Protocol Access Hyperlink:   75276617ALE1001_Shah
			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Performance status:  Refer to Section 5.1 and Section 10.16 or Oken 1982 for age appropriate application.
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Complete Physical examination
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Patient-reported outcomes
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Patient-reported outcomes
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs:  Temperature, heart rate, and blood pressure. Refer to Section 8.2.3.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	BM aspirate:  DE Sampling Timepoints (±3D): C2D1; C3D1; C5D1; C7D1; then every 3 cycles (±1 week); EOT; and as clinically indicated.  Local CBCs (including circulating blasts) are drawn at the time of DE (±3d) and <=14 days after DE for response assessment
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood:  DE Sampling Timepoints (±3D): C2D1; C3D1; C5D1; C7D1; then every 3 cycles (±1 week); EOT; and as clinically indicated.  Local CBCs (including circulating blasts) are drawn at the time of DE (±3d) and <=14 days after DE for response assessment
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	GGT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	LDH	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CHOLESTEROL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Medications
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Provider Communication
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib accountability:  In addition to drug accountability, monitor compliance on an ongoing basis per institutional standards. Refer to Sections 6.2 and 6.3.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study drug will be administered in the clinic on the days that PK samples are obtained (PK samples and Study drug will be administered on C1D1, C1D15, C2D1)
					
Cycle 6	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    75276617ALE1001_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Dose Modifications and Management for  Treatment Bleximenib : Refer to Section 6.5 Protocol Access Hyperlink:   75276617ALE1001_Shah
			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Performance status:  Refer to Section 5.1 and Section 10.16 or Oken 1982 for age appropriate application.
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs:  Temperature, heart rate, and blood pressure. Refer to Section 8.2.3.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	GGT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	LDH	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CHOLESTEROL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Medications
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Provider Communication
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib accountability:  In addition to drug accountability, monitor compliance on an ongoing basis per institutional standards. Refer to Sections 6.2 and 6.3.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study drug will be administered in the clinic on the days that PK samples are obtained (PK samples and Study drug will be administered on C1D1, C1D15, C2D1)
					
Cycle 7	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    75276617ALE1001_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Dose Modifications and Management for  Treatment Bleximenib : Refer to Section 6.5 Protocol Access Hyperlink:   75276617ALE1001_Shah
			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Performance status:  Refer to Section 5.1 and Section 10.16 or Oken 1982 for age appropriate application.
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs:  Temperature, heart rate, and blood pressure. Refer to Section 8.2.3.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	BM aspirate:  DE Sampling Timepoints (±3D): C2D1; C3D1; C5D1; C7D1; then every 3 cycles (±1 week); EOT; and as clinically indicated.  Local CBCs (including circulating blasts) are drawn at the time of DE (±3d) and <=14 days after DE for response assessment
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood:  DE Sampling Timepoints (±3D): C2D1; C3D1; C5D1; C7D1; then every 3 cycles (±1 week); EOT; and as clinically indicated.  Local CBCs (including circulating blasts) are drawn at the time of DE (±3d) and <=14 days after DE for response assessment
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	GGT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	LDH	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CHOLESTEROL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Medications
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Provider Communication
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib accountability:  In addition to drug accountability, monitor compliance on an ongoing basis per institutional standards. Refer to Sections 6.2 and 6.3.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study drug will be administered in the clinic on the days that PK samples are obtained (PK samples and Study drug will be administered on C1D1, C1D15, C2D1)
					
Cycle 8	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    75276617ALE1001_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Dose Modifications and Management for  Treatment Bleximenib : Refer to Section 6.5 Protocol Access Hyperlink:   75276617ALE1001_Shah
			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Performance status:  Refer to Section 5.1 and Section 10.16 or Oken 1982 for age appropriate application.
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs:  Temperature, heart rate, and blood pressure. Refer to Section 8.2.3.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	GGT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	LDH	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CHOLESTEROL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Medications
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Provider Communication
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib accountability:  In addition to drug accountability, monitor compliance on an ongoing basis per institutional standards. Refer to Sections 6.2 and 6.3.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study drug will be administered in the clinic on the days that PK samples are obtained (PK samples and Study drug will be administered on C1D1, C1D15, C2D1)
					
Cycle 9	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    75276617ALE1001_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Dose Modifications and Management for  Treatment Bleximenib : Refer to Section 6.5 Protocol Access Hyperlink:   75276617ALE1001_Shah
			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Performance status:  Refer to Section 5.1 and Section 10.16 or Oken 1982 for age appropriate application.
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs:  Temperature, heart rate, and blood pressure. Refer to Section 8.2.3.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	GGT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	LDH	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CHOLESTEROL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Medications
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Provider Communication
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib accountability:  In addition to drug accountability, monitor compliance on an ongoing basis per institutional standards. Refer to Sections 6.2 and 6.3.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study drug will be administered in the clinic on the days that PK samples are obtained (PK samples and Study drug will be administered on C1D1, C1D15, C2D1)
					
Cycle 10	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    75276617ALE1001_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Dose Modifications and Management for  Treatment Bleximenib : Refer to Section 6.5 Protocol Access Hyperlink:   75276617ALE1001_Shah
			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Performance status:  Refer to Section 5.1 and Section 10.16 or Oken 1982 for age appropriate application.
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs:  Temperature, heart rate, and blood pressure. Refer to Section 8.2.3.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	BM aspirate:  DE Sampling Timepoints (±3D): C2D1; C3D1; C5D1; C7D1; then every 3 cycles (±1 week); EOT; and as clinically indicated.  Local CBCs (including circulating blasts) are drawn at the time of DE (±3d) and <=14 days after DE for response assessment
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood:  DE Sampling Timepoints (±3D): C2D1; C3D1; C5D1; C7D1; then every 3 cycles (±1 week); EOT; and as clinically indicated.  Local CBCs (including circulating blasts) are drawn at the time of DE (±3d) and <=14 days after DE for response assessment
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	GGT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	LDH	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CHOLESTEROL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Medications
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Provider Communication
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib accountability:  In addition to drug accountability, monitor compliance on an ongoing basis per institutional standards. Refer to Sections 6.2 and 6.3.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study drug will be administered in the clinic on the days that PK samples are obtained (PK samples and Study drug will be administered on C1D1, C1D15, C2D1)
					
Cycle 11	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    75276617ALE1001_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Dose Modifications and Management for  Treatment Bleximenib : Refer to Section 6.5 Protocol Access Hyperlink:   75276617ALE1001_Shah
			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Performance status:  Refer to Section 5.1 and Section 10.16 or Oken 1982 for age appropriate application.
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs:  Temperature, heart rate, and blood pressure. Refer to Section 8.2.3.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	GGT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	LDH	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CHOLESTEROL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Medications
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Provider Communication
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib accountability:  In addition to drug accountability, monitor compliance on an ongoing basis per institutional standards. Refer to Sections 6.2 and 6.3.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study drug will be administered in the clinic on the days that PK samples are obtained (PK samples and Study drug will be administered on C1D1, C1D15, C2D1)
					
Cycle 12	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    75276617ALE1001_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Dose Modifications and Management for  Treatment Bleximenib : Refer to Section 6.5 Protocol Access Hyperlink:   75276617ALE1001_Shah
			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Performance status:  Refer to Section 5.1 and Section 10.16 or Oken 1982 for age appropriate application.
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs:  Temperature, heart rate, and blood pressure. Refer to Section 8.2.3.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	GGT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	LDH	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CHOLESTEROL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Medications
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Provider Communication
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib accountability:  In addition to drug accountability, monitor compliance on an ongoing basis per institutional standards. Refer to Sections 6.2 and 6.3.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study drug will be administered in the clinic on the days that PK samples are obtained (PK samples and Study drug will be administered on C1D1, C1D15, C2D1)
					
Cycle 13	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    75276617ALE1001_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Dose Modifications and Management for  Treatment Bleximenib : Refer to Section 6.5 Protocol Access Hyperlink:   75276617ALE1001_Shah
			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Performance status:  Refer to Section 5.1 and Section 10.16 or Oken 1982 for age appropriate application.
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs:  Temperature, heart rate, and blood pressure. Refer to Section 8.2.3.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	BM aspirate:  DE Sampling Timepoints (±3D): C2D1; C3D1; C5D1; C7D1; then every 3 cycles (±1 week); EOT; and as clinically indicated.  Local CBCs (including circulating blasts) are drawn at the time of DE (±3d) and <=14 days after DE for response assessment
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood:  DE Sampling Timepoints (±3D): C2D1; C3D1; C5D1; C7D1; then every 3 cycles (±1 week); EOT; and as clinically indicated.  Local CBCs (including circulating blasts) are drawn at the time of DE (±3d) and <=14 days after DE for response assessment
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	GGT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	LDH	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CHOLESTEROL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Medications
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Provider Communication
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib accountability:  In addition to drug accountability, monitor compliance on an ongoing basis per institutional standards. Refer to Sections 6.2 and 6.3.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study drug will be administered in the clinic on the days that PK samples are obtained (PK samples and Study drug will be administered on C1D1, C1D15, C2D1)
					
Cycle 15	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    75276617ALE1001_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Dose Modifications and Management for  Treatment Bleximenib : Refer to Section 6.5 Protocol Access Hyperlink:   75276617ALE1001_Shah
			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Performance status:  Refer to Section 5.1 and Section 10.16 or Oken 1982 for age appropriate application.
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs:  Temperature, heart rate, and blood pressure. Refer to Section 8.2.3.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	GGT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	LDH	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CHOLESTEROL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Medications
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Provider Communication
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib accountability:  In addition to drug accountability, monitor compliance on an ongoing basis per institutional standards. Refer to Sections 6.2 and 6.3.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study drug will be administered in the clinic on the days that PK samples are obtained (PK samples and Study drug will be administered on C1D1, C1D15, C2D1)
					
Cycle 16	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    75276617ALE1001_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Dose Modifications and Management for  Treatment Bleximenib : Refer to Section 6.5 Protocol Access Hyperlink:   75276617ALE1001_Shah
			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Performance status:  Refer to Section 5.1 and Section 10.16 or Oken 1982 for age appropriate application.
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs:  Temperature, heart rate, and blood pressure. Refer to Section 8.2.3.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	BM aspirate:  DE Sampling Timepoints (±3D): C2D1; C3D1; C5D1; C7D1; then every 3 cycles (±1 week); EOT; and as clinically indicated.  Local CBCs (including circulating blasts) are drawn at the time of DE (±3d) and <=14 days after DE for response assessment
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood:  DE Sampling Timepoints (±3D): C2D1; C3D1; C5D1; C7D1; then every 3 cycles (±1 week); EOT; and as clinically indicated.  Local CBCs (including circulating blasts) are drawn at the time of DE (±3d) and <=14 days after DE for response assessment
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	GGT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	LDH	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CHOLESTEROL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Medications
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Provider Communication
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib accountability:  In addition to drug accountability, monitor compliance on an ongoing basis per institutional standards. Refer to Sections 6.2 and 6.3.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study drug will be administered in the clinic on the days that PK samples are obtained (PK samples and Study drug will be administered on C1D1, C1D15, C2D1)
					
Cycle 17	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    75276617ALE1001_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Dose Modifications and Management for  Treatment Bleximenib : Refer to Section 6.5 Protocol Access Hyperlink:   75276617ALE1001_Shah
			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Performance status:  Refer to Section 5.1 and Section 10.16 or Oken 1982 for age appropriate application.
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs:  Temperature, heart rate, and blood pressure. Refer to Section 8.2.3.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	GGT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	LDH	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CHOLESTEROL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Medications
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Provider Communication
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib accountability:  In addition to drug accountability, monitor compliance on an ongoing basis per institutional standards. Refer to Sections 6.2 and 6.3.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study drug will be administered in the clinic on the days that PK samples are obtained (PK samples and Study drug will be administered on C1D1, C1D15, C2D1)
					
Cycle 18	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    75276617ALE1001_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Dose Modifications and Management for  Treatment Bleximenib : Refer to Section 6.5 Protocol Access Hyperlink:   75276617ALE1001_Shah
			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Performance status:  Refer to Section 5.1 and Section 10.16 or Oken 1982 for age appropriate application.
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs:  Temperature, heart rate, and blood pressure. Refer to Section 8.2.3.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	GGT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	LDH	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CHOLESTEROL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Medications
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Provider Communication
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib accountability:  In addition to drug accountability, monitor compliance on an ongoing basis per institutional standards. Refer to Sections 6.2 and 6.3.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study drug will be administered in the clinic on the days that PK samples are obtained (PK samples and Study drug will be administered on C1D1, C1D15, C2D1)
					
Cycle 19	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    75276617ALE1001_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Dose Modifications and Management for  Treatment Bleximenib : Refer to Section 6.5 Protocol Access Hyperlink:   75276617ALE1001_Shah
			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Performance status:  Refer to Section 5.1 and Section 10.16 or Oken 1982 for age appropriate application.
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs:  Temperature, heart rate, and blood pressure. Refer to Section 8.2.3.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	BM aspirate:  DE Sampling Timepoints (±3D): C2D1; C3D1; C5D1; C7D1; then every 3 cycles (±1 week); EOT; and as clinically indicated.  Local CBCs (including circulating blasts) are drawn at the time of DE (±3d) and <=14 days after DE for response assessment
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood:  DE Sampling Timepoints (±3D): C2D1; C3D1; C5D1; C7D1; then every 3 cycles (±1 week); EOT; and as clinically indicated.  Local CBCs (including circulating blasts) are drawn at the time of DE (±3d) and <=14 days after DE for response assessment
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	GGT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	LDH	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CHOLESTEROL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Medications
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Provider Communication
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib accountability:  In addition to drug accountability, monitor compliance on an ongoing basis per institutional standards. Refer to Sections 6.2 and 6.3.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study drug will be administered in the clinic on the days that PK samples are obtained (PK samples and Study drug will be administered on C1D1, C1D15, C2D1)
					
Cycle 20	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    75276617ALE1001_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Dose Modifications and Management for  Treatment Bleximenib : Refer to Section 6.5 Protocol Access Hyperlink:   75276617ALE1001_Shah
			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Performance status:  Refer to Section 5.1 and Section 10.16 or Oken 1982 for age appropriate application.
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs:  Temperature, heart rate, and blood pressure. Refer to Section 8.2.3.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	GGT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	LDH	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CHOLESTEROL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Medications
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Provider Communication
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib accountability:  In addition to drug accountability, monitor compliance on an ongoing basis per institutional standards. Refer to Sections 6.2 and 6.3.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study drug will be administered in the clinic on the days that PK samples are obtained (PK samples and Study drug will be administered on C1D1, C1D15, C2D1)
					
Cycle 21	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    75276617ALE1001_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Dose Modifications and Management for  Treatment Bleximenib : Refer to Section 6.5 Protocol Access Hyperlink:   75276617ALE1001_Shah
			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Performance status:  Refer to Section 5.1 and Section 10.16 or Oken 1982 for age appropriate application.
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs:  Temperature, heart rate, and blood pressure. Refer to Section 8.2.3.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	GGT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	LDH	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CHOLESTEROL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Medications
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Provider Communication
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib accountability:  In addition to drug accountability, monitor compliance on an ongoing basis per institutional standards. Refer to Sections 6.2 and 6.3.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study drug will be administered in the clinic on the days that PK samples are obtained (PK samples and Study drug will be administered on C1D1, C1D15, C2D1)
					
Cycle 22	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    75276617ALE1001_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Dose Modifications and Management for  Treatment Bleximenib : Refer to Section 6.5 Protocol Access Hyperlink:   75276617ALE1001_Shah
			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Performance status:  Refer to Section 5.1 and Section 10.16 or Oken 1982 for age appropriate application.
			Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs:  Temperature, heart rate, and blood pressure. Refer to Section 8.2.3.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	BM aspirate:  DE Sampling Timepoints (±3D): C2D1; C3D1; C5D1; C7D1; then every 3 cycles (±1 week); EOT; and as clinically indicated.  Local CBCs (including circulating blasts) are drawn at the time of DE (±3d) and <=14 days after DE for response assessment
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood:  DE Sampling Timepoints (±3D): C2D1; C3D1; C5D1; C7D1; then every 3 cycles (±1 week); EOT; and as clinically indicated.  Local CBCs (including circulating blasts) are drawn at the time of DE (±3d) and <=14 days after DE for response assessment
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	GGT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	LDH	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CHOLESTEROL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Medications
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Provider Communication
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib 100mg twice daily for oral dosing.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bleximenib accountability:  In addition to drug accountability, monitor compliance on an ongoing basis per institutional standards. Refer to Sections 6.2 and 6.3.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Study drug will be administered in the clinic on the days that PK samples are obtained (PK samples and Study drug will be administered on C1D1, C1D15, C2D1)
					
EOT	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    75276617ALE1001_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Dose Modifications and Management for  Treatment Bleximenib : Refer to Section 6.5 Protocol Access Hyperlink:   75276617ALE1001_Shah
			Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	BM aspirate:  DE Sampling Timepoints (±3D): C2D1; C3D1; C5D1; C7D1; then every 3 cycles (±1 week); EOT; and as clinically indicated.  Local CBCs (including circulating blasts) are drawn at the time of DE (±3d) and <=14 days after DE for response assessment
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood:  DE Sampling Timepoints (±3D): C2D1; C3D1; C5D1; C7D1; then every 3 cycles (±1 week); EOT; and as clinically indicated.  Local CBCs (including circulating blasts) are drawn at the time of DE (±3d) and <=14 days after DE for response assessment
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	GGT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	LDH	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CHOLESTEROL	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	C-REACTIVE PROTEIN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		☑	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	FERRITIN LEVEL	Interval: --	Occurrences: --		  	TRIGLYCERIDES	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Labs
  	PT AND PTT	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		  	FIBRINOGEN	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
		  	D-DIMER	Interval: --	Occurrences: --	Comments:	If screening hematology or chemistry performed >48 hrs prior to first dose, retest to confirm eligibility within 48 hrs of first dose. Testing by local laboratory; refer to Section 8.2.5 and Section 10.2 for required tests Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of emerging signs or symptoms that may be associated with DS (see Section 6.5.1.2.3).  Additional unscheduled visits/assessments for enhanced clinical and laboratory monitoring should be conducted as clinically indicated to enable recognition and management of potential emerging toxicities, including signs or symptoms that may be associated with DS (see Section 6.5.1.2.2).
					
LTFU	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Subsequent therapies, SPM, and response/survival status:  Information may be obtained via virtual (eg, telephone) contact; response status to be collected for responders who discontinue treatment for reasons other than relapsed disease