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OP RSH PRO00045037 75276617AML3001 SHAH SCREENING	

Types:      Research Oncology Treatment
Synonyms:  PRO00045037, 75276617AML3001 SHAH, BLEXIMENIB, VENETOCLAX, AZACITIDINE, LEUKEMIA [10011]

Screening ( -28 to -1 Day)	Repeat 1 time	Cycle length: 28 days	Screening ( -28 to -1 Day)	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING 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: 75276617AML3001_Shah
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  Treatment: Refer to Section 6.6 Protocol Access Hyperlink:   75276617AML3001_Shah
			Nursing Orders
  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Informed consent/ medical history
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	KMT2Ar, NPM1m, FLT3 status. By local testing (Section 8.1)
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG PS score
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Physical examination.A full physical examination includes head and neck, cardiac, respiratory, abdominal, neurological, musculoskeletal, and skin examinations. Section 8.3.2 specifies that a focused physical examination will be conducted at subsequent study visits.
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	EMD evaluation. To be done with every BM assessment
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Transfusion status
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	AEs and concomitant therapy. From the signing of ICF until 30 days after the study treatment discontinuation or until the start of subsequent anti-AML therapy, if earlier
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Must be taken on the day of or the day prior to dosing, and results must be available before study drug is administered
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Must be taken on the day of or the day prior to dosing, and results must be available before study drug is administered
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	Must be taken on the day of or the day prior to dosing, and results must be available before study drug is administered
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	Must be taken on the day of or the day prior to dosing, and results must be available before study drug is administered
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.Urine or serum -hCG
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Urine or serum -hCG
		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE AB, QUANTITATIVE	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY IGM	Interval: --	Occurrences: --		  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	HCV is not required and completed only as clinical indicated
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspiration/ Bone marrow biopsy(BMA/BMB ) and hematology (including peripheral blast count). Collect at Screening (BMA and Peripheral Blood )
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspiration (BMA) (first pull preferred) and PB for central mutation testing AND/OR MRD/Biomarkers