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OP RESEARCH PRO00038342 / ALE1001 SHAH SCREENING PHASE 2	

Types:      Research Oncology Treatment
Synonyms:  PRE-SCREENING, LEUKEMIA, BASELINE

Screening	Repeat 1 time	Cycle length: 28 days	Day -28	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
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Informed consent/assent:  Refer to Section 10.3.3.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Eligibility criteria:  Refer to Sections 5.1 and 5.2.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Demography
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Medical history:  Medical history to include ongoing relevant and clinically significant comorbidities (including NCI-CTCAE severity grade), and prior anticancer therapies and procedures.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Disease characteristics:  Includes cytogenetics, molecular genetics, and information on EMD, as applicable.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Local KMT2A, NPM1
		  	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.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Complete Physical examination:  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). Refer to Section 8.2.1.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Adverse events:  From the signing of ICF until EOT visit completion or start of first subsequent anticancer therapy, if earlier.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Concomitant therapy:  From the signing of ICF until EOT visit completion or start of first subsequent anticancer therapy, if earlier.
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	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:  Local (non-triplicate) ECG at Screening. Refer to Section 8.2.4.
			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).
		☑	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).
		☑	FERRITIN 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).
		☑	TRIGLYCERIDES	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).
		☑	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).
		☑	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.
			Labs
  	HEPATITIS C VIRUS (HCV) ANTIBODY WITH REFLEX TO PCR	Interval: --	Occurrences: --			Labs
  	HEPATITIS B CORE ANTIBODY IGM	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --			Labs
  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	DE(BM and PB [CBC with differential and circulating blasts]):  DE visits include EMD assessments, as applicable. BM aspirate is preferred; if dry tap, BM biopsy should be obtained.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole blood