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PRO00039821 / AC220-167 / BASELINE / SCREENING	

Types:      Research Oncology Treatment
Synonyms:  PRE-SCREENING, BASELINE, AML, AC220, 167

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:    AC220-167_Shah
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for QUIZARTINIB Treatment: Refer to Section 6.5
Protocol Access Hyperlink:  AC220-167_Shah
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Main ICF
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Eligibility Criteria
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Demographics

Includes age, sex, race, and ethnicity (as
allowed per local regulations).
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	AML FLT3-ITD (+) Disease Status 

Provide diagnostic reports of AML FLT3-ITD (+) at the time of initial AML diagnosis. Reports must include FLT3- ITD positivity from BMA or blood
based on local assessment. The test result with the specific VAF or SR value and type of assay to detect FLT3-ITD positivity must be recorded in eCRF.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Medical History.

Record all relevant medical history.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Physical exam
		  	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:	ECOG PS
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	AEs/SAEs
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/
Concomitant
Therapies
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior Induction/
Consolidation
Therapy
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Subsequent
Anticancer
Treatment
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bone Marrow Assessment 

Local BM assessment must be performed to confirm ongoing CR within 28 days prior to the first day of
the maintenance cycle, which may coincide with the last BM
aspirate/biopsy specimen collection of the consolidation phase.
			Procedures
  	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	If procedure was performed within 28 days of entering the study an additional ECHO/MUGA is not required at the time of screening.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be sent for central reading.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be sent for central reading.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be sent for central reading.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local laboratory testing. Within 7 days prior to enrollment. Hemoglobin,hematocrit,platelet count
RBC count,WBC count, differential WBC count (% and absolute count) Table 10.1
		  	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 BM assessment must be performed to confirm ongoing CR within 28 days prior to the first day of
the maintenance cycle, which may coincide with the last BM
aspirate/biopsy specimen collection of the consolidation phase.