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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 -14 to 1	Perform every 1 day x1			Research tolerance: -0/+0 days	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: Obtain prior to performing any trial procedures not covered by Biosample Screening ICF. Main ICF must be signed prior to start of chemotherapy.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Assign PID. PID obtained either on the day of Biosample Screening ICF or Main ICF, whichever is first
		  	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 (central): At Biosample Screening or Main Screening, a bone marrow aspirate (BMA) specimen and a peripheral blood sample are required for FLT3-ITD testing. If an aspirate sample cannot be obtained, a peripheral blood sample will be sent to the central laboratory for assessment of FLT3-ITD activating mutation.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Molecular Testing: FISH, Karyotyping, and NGS (central) : At Biosample Screening or Main Screening, a BMA specimen and peripheral blood sample are required for molecular testing (FISH, karyotyping and NGS) and should be sent to the central laboratory. Results from FISH and NGS for stratification by adverse vs nonadverse risk group will be available at randomization. If central results are delayed, local assessments per standard of care may be utilized for stratification. If adequate BMA specimen is not available, refer to regional laboratory documents to determine if an alternate sample type may be utilized. Karyotyping will be used together with FISH and NGS for subgroup analysis by ELN 2022 classification.
		  	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 : Only (S)AEs related to trial procedures should be recorded during the Biosample SCR period. Only non-serious AEs related to protocol-specified procedure or intervention or any SAE should be reported after participant provides documented informed consent, but before first dose of trial intervention.
		  	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 Collection : Bone marrow sample should be collected prior to starting 7+3 Chemotherapy
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Exploratory Biomarker Assessment (central): Collect and analyze bone marrow aspirate sample.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	FLT3-ITD NGS
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	MRD Assessment (central) ; MRD to be analyzed by FLT3-ITD and flow cytometry for all participants. Analyze NPM1 and CBF for participants positive at screening.Samples to be analyzed from bone marrow aspirate and/or peripheral blood. Refer to regionally specific flow chart for further details. MRD assessment should be collected at EOT from bone marrow preferentially if available or blood if bone marrow is not available.Refer to Table 8.11 for specific MRD assessment time points.
		  	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.
			Procedures
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Morphology (local and central) .Aspirate specimens will be sent to the local laboratory for morphology assessment. If an adequate aspirate specimen cannot be collected, a core biopsy specimen may be used. Collect a copy of the de-identified local pathology report for submission to the IRC.Central collection and submission of aspirate specimen is applicable only to samples from Screening and Induction Cycle 1. If adequate BMA specimen is not available, refer to regional laboratory documents to determine if an alternate sample type may be utilized.