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OP RESEARCH PRO00038439 / AC220-168 SCREENING / BASELINE	

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

Screening / Baseline	Repeat 1 time	Cycle length: 28 days	Day -7 to 6	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: AC220-168_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Treatment: Refer to Section 6.6 (Guidelines for Dose Modification) Management of AEs Associated with quizartinib 
Protocol Access Hyperlink: [CG1] AC220-168_Shah
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Informed Consent Main ICF: Participants may need to sign a separate consent during Screening to allow for FLT3-ITD testing, patient stratification assessment, and additional biomarker analysis. ELN classification samples to be sent to a central laboratory, in accordance with local procedures.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Assign SID
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Eligibility Assessment
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Demographics
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	FLT3 Mutation Status Enrollment Assay
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Molecular Testing: FISH, Karyotyping, and NGS (central): At Screening, a bone marrow aspirate (BMA) specimen and peripheral blood sample are required for molecular testing (FISH, karyotyping and NGS) and should be sent to the central laboratory.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Medical/surgical History
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Respiratory rate, heart rate, systolic and diastolic blood pressures, temperature, and body weight
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	BSA
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	ECOG Performance Status:  To be collected prior to initiation of chemotherapy on Cycle 1 Day 1.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse Events
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior Medications
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant Medications
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Local and Central Bone Marrow Assessment:  Bone marrow aspiration
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Exploratory Biomarker Assessment
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	FLT3-ITD NGS
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	MRD Assessment
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	EORTC QLQC30, PGI-S, EQ- 5D-5L
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
			Procedures
  	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --		  	NM X GATED BLOOD POOL SINGLE (MUGA RESTING)	Interval: --	Occurrences: --		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Electrocardiography (ECG) will be performed at screening and when clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	PT AND PTT	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --		  	ACUTE VIRAL HEPATITIS PANEL (HAV, HBV, HCV)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Local and central assessment.  Aspirate specimens will be sent to both the local and the central laboratory.