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PRO00039821 / AC220-167 / SUB STUDY	

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

Screening / Baseline	Repeat 1 time	Cycle length: 28 days	Day -28 to -1	Perform every 1 day x1			Research tolerance: -28/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Sub-study informed consent :Obtain prior to performing any trial procedures.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Eligibility assessment : Review all inclusion/exclusion criteria to determine eligibility.Participants must meet all eligibility criteria defined in the main trial protocol and the additional
eligibility criteria for participation in this sub-study (see Section 5.1 and Section 5.2).
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Record concomitant medications : Participants on beta-blockers (3 participants as a maximum and 1 participant as a minimum in each treatment arm) are allowed to participate in the sub-study. Participants who received quizartinib or midostaurin before enrollment will have a washout period (14 days).
				Day -4 to -1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	CV HOLTER MONITOR 24 HOUR	Interval: --	Occurrences: --	Comments:	24H Holter : Holter will be placed on the participant at baseline (between C1D-4 and C1D-1) and postbaseline
(C2D1) during 24H. Central read of the 24H Holter ECGs will be performed for the analysis. The participant will undergo postural provocation in 4 hours after dosing in C2D1 and 4 hours after planned dosing in C1D-4 to C1D-1 for baseline. After completion of assessment (24H), the Holter device will be returned.
* Baseline after 14 days washout period if prior quizartinib/midostaurin received.
** The second Holter must be performed on C2D1 after a minimum of two weeks of continuous daily dosing at the assigned dose prior to the second Holter assessment. If a participant has not been on the assigned dose for two weeks by C2D1, the second Holter assessment can be performed as soon as possible during C2 once they have received the assigned dose for at least two weeks.
					
Cycle 1	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	CV HOLTER MONITOR 24 HOUR	Interval: --	Occurrences: --	Comments:	24H Holter : Holter will be placed on the participant at baseline (between C1D-4 and C1D-1) and postbaseline
(C2D1) during 24H. Central read of the 24H Holter ECGs will be performed for the analysis. The participant will undergo postural provocation in 4 hours after dosing in C2D1 and 4 hours after planned dosing in C1D-4 to C1D-1 for baseline. After completion of assessment (24H), the Holter device will be returned.
* Baseline after 14 days washout period if prior quizartinib/midostaurin received.
** The second Holter must be performed on C2D1 after a minimum of two weeks of continuous daily dosing at the assigned dose prior to the second Holter assessment. If a participant has not been on the assigned dose for two weeks by C2D1, the second Holter assessment can be performed as soon as possible during C2 once they have received the assigned dose for at least two weeks.
					
Cycle 2	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	CV HOLTER MONITOR 24 HOUR	Interval: --	Occurrences: --	Comments:	24H Holter : Holter will be placed on the participant at baseline (between C1D-4 and C1D-1) and postbaseline
(C2D1) during 24H. Central read of the 24H Holter ECGs will be performed for the analysis. The participant will undergo postural provocation in 4 hours after dosing in C2D1 and 4 hours after planned dosing in C1D-4 to C1D-1 for baseline. After completion of assessment (24H), the Holter device will be returned.
* Baseline after 14 days washout period if prior quizartinib/midostaurin received.
** The second Holter must be performed on C2D1 after a minimum of two weeks of continuous daily dosing at the assigned dose prior to the second Holter assessment. If a participant has not been on the assigned dose for two weeks by C2D1, the second Holter assessment can be performed as soon as possible during C2 once they have received the assigned dose for at least two weeks.