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PRO00039821 / AC220-167 / ARM 2	

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

Cycle 1	Repeat 1 time	Cycle length: 28 days	Day 1	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	Interval: --	Occurrences: --	Comments:	If screening assessment was performed within 3 days of the first dose, it does not need to be repeated.
Vital signs will include the measurements of respiratory rate, heart rate, systolic and diastolic blood pressures, temperature, and body weight. Blood pressure and pulse rate will be measured after the participant has rested in a recumbent position for 5 minutes or more and prior to laboratory draws
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please follow the order: vital signs, blood draws, and treatment.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG PS
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	AEs/SAEs

Only non-serious AEs related to protocol specified procedure or intervention or any SAE should be
reported after ICF, but before first dose of quizartinib.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/
Concomitant
Therapies

Specific induction and consolidation chemotherapy regimens used must be recorded.
The use of FLT3 inhibitors during induction
and consolidation must be precisely recorded, including information about the administration of midostaurin, quizartinib, other FLT3 inhibitors or none.
			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: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Pharmacokinetic Instructions
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	PK blood sampling times -0.5 to
0 hours (predose) on C1D1, C1D15,
and C2D1, and 2 to 4 hours (postdose)
on C1D1, C1D8, C1D15, C1D21
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ePRO mobile
application
setup, device
allocation,
Training

ePRO application setup on participant's personal device (phone/tablet) or provisioned handheld (if participant
does not own suitable device)
Training to be administered before any other assessments 

modules
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	EORTC
QLQ-C30
Modules

The pretreatment (baseline) PRO
assessment is to be administered before
the participant has knowledge of the
treatment assignment.
PROs are to be administered to the
participant prior to any other
assessments.
3 C15 - C36 assessment window will be
+/- 2 days in relation to CxD1
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	FACIT-GP5

The pretreatment (baseline) PRO assessment is to be administered before the participant has knowledge of the treatment assignment PROs are to be administered to the participant prior to any other assessments.
FACIT-GP5 is to be administered from C1D8 onward.
Have a 40-hour window before the due date.
C15 - C36 assessment window will be +/- 2 days in relation to CxD1
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PRO-CTCAE

Have a 40-hour window before the due date.
C15 - C36 assessment window will be +/- 2 days in relation to CxD1
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Response/
Relapse
Assessment

based on local assessments using local hematology laboratory performed every month during the first 12 cycles of quizartinib maintenance as single agent
and every 3 months during the second and third year of maintenance. In case of abnormal CBC results suspicious of relapse, a bone marrow assessment and
CBC with manual differential should be performed and response assessment should be reported in the source
document and eCRF with date of relapse documented in the eCRF. Mandatory bone marrow assessments
are required at Screening, at the end of treatment (EOT) only. In addition,every BMA performed by the site
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bone Marrow Assessment

If clinically indicated, EOT

Bone marrow will be mandatory only if AML relapse is suspected and at the EOT. Every BM assessment performed by local practice must be reported in source documents and in the eCRF.
			Nursing Orders
  	TREATMENT CONDITIONS 4	Interval: --	Occurrences: --	Comments:	If the patient experiences nausea and/or vomiting after the first dose of quizartinib, the participant should receive antiemetics as clinically indicated prior to and after administration of quizartinib. 
Provider should be contacted to send scripts for antiemetics, if warranted.
			Nursing Orders
  	TREATMENT CONDITIONS 4	Interval: --	Occurrences: --	Comments:	If the patients QTc is >480 ms, notify provider
			Nursing Orders
  	TREATMENT CONDITIONS 4	Interval: --	Occurrences: --	Comments:	If potassium is LESS THAN 3 mmol/L, notify provider
If magnesium is LESS THAN 0.9 mg/dL, notify provider
		  	TREATMENT CONDITIONS 4	Interval: --	Occurrences: --	Comments:	If AST or ALT is GREATER than >5 × ULN, notify provider
If total bilirubin is GREATER THAN 3 × ULN, notify provider
			Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Patients will be started on quizartinib 30 mg once daily for all days.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Quizartinib 30 mg PO once daily
				Day 8	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	Interval: --	Occurrences: --	Comments:	If screening assessment was performed within 3 days of the first dose, it does not need to be repeated.
Vital signs will include the measurements of respiratory rate, heart rate, systolic and diastolic blood pressures, temperature, and body weight. Blood pressure and pulse rate will be measured after the participant has rested in a recumbent position for 5 minutes or more and prior to laboratory draws
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	AEs/SAEs

Only non-serious AEs related to protocol specified procedure or intervention or any SAE should be
reported after ICF, but before first dose of quizartinib.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/
Concomitant
Therapies

Specific induction and consolidation chemotherapy regimens used must be recorded.
The use of FLT3 inhibitors during induction
and consolidation must be precisely recorded, including information about the administration of midostaurin, quizartinib, other FLT3 inhibitors or none.
			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: --			Pharmacokinetic Instructions
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	PK blood sampling times -0.5 to
0 hours (predose) on C1D1, C1D15,
and C2D1, and 2 to 4 hours (postdose)
on C1D1, C1D8, C1D15, C1D21
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	FACIT-GP5

The pretreatment (baseline) PRO assessment is to be administered before the participant has knowledge of the treatment assignment PROs are to be administered to the participant prior to any other assessments.
FACIT-GP5 is to be administered from C1D8 onward.
Have a 40-hour window before the due date.
C15 - C36 assessment window will be +/- 2 days in relation to CxD1
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PRO-CTCAE

Have a 40-hour window before the due date.
C15 - C36 assessment window will be +/- 2 days in relation to CxD1
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Response/
Relapse
Assessment

based on local assessments using local hematology laboratory performed every month during the first 12 cycles of quizartinib maintenance as single agent
and every 3 months during the second and third year of maintenance. In case of abnormal CBC results suspicious of relapse, a bone marrow assessment and
CBC with manual differential should be performed and response assessment should be reported in the source
document and eCRF with date of relapse documented in the eCRF. Mandatory bone marrow assessments
are required at Screening, at the end of treatment (EOT) only. In addition,every BMA performed by the site
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bone Marrow Assessment

If clinically indicated, EOT

Bone marrow will be mandatory only if AML relapse is suspected and at the EOT. Every BM assessment performed by local practice must be reported in source documents and in the eCRF.
			Nursing Orders
  	TREATMENT CONDITIONS 4	Interval: --	Occurrences: --	Comments:	If the patient experiences nausea and/or vomiting after the first dose of quizartinib, the participant should receive antiemetics as clinically indicated prior to and after administration of quizartinib. 
Provider should be contacted to send scripts for antiemetics, if warranted.
			Nursing Orders
  	TREATMENT CONDITIONS 4	Interval: --	Occurrences: --	Comments:	If the patients QTc is >480 ms, notify provider
			Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Patients will be started on quizartinib 30 mg once daily for all days.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Quizartinib 30 mg PO once daily
				Day 15	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	Interval: --	Occurrences: --	Comments:	If screening assessment was performed within 3 days of the first dose, it does not need to be repeated.
Vital signs will include the measurements of respiratory rate, heart rate, systolic and diastolic blood pressures, temperature, and body weight. Blood pressure and pulse rate will be measured after the participant has rested in a recumbent position for 5 minutes or more and prior to laboratory draws
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	AEs/SAEs

Only non-serious AEs related to protocol specified procedure or intervention or any SAE should be
reported after ICF, but before first dose of quizartinib.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/
Concomitant
Therapies

Specific induction and consolidation chemotherapy regimens used must be recorded.
The use of FLT3 inhibitors during induction
and consolidation must be precisely recorded, including information about the administration of midostaurin, quizartinib, other FLT3 inhibitors or none.
			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: --			Pharmacokinetic Instructions
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	PK blood sampling times -0.5 to
0 hours (predose) on C1D1, C1D15,
and C2D1, and 2 to 4 hours (postdose)
on C1D1, C1D8, C1D15, C1D21
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	FACIT-GP5

The pretreatment (baseline) PRO assessment is to be administered before the participant has knowledge of the treatment assignment PROs are to be administered to the participant prior to any other assessments.
FACIT-GP5 is to be administered from C1D8 onward.
Have a 40-hour window before the due date.
C15 - C36 assessment window will be +/- 2 days in relation to CxD1
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PRO-CTCAE

Have a 40-hour window before the due date.
C15 - C36 assessment window will be +/- 2 days in relation to CxD1
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Response/
Relapse
Assessment

based on local assessments using local hematology laboratory performed every month during the first 12 cycles of quizartinib maintenance as single agent
and every 3 months during the second and third year of maintenance. In case of abnormal CBC results suspicious of relapse, a bone marrow assessment and
CBC with manual differential should be performed and response assessment should be reported in the source
document and eCRF with date of relapse documented in the eCRF. Mandatory bone marrow assessments
are required at Screening, at the end of treatment (EOT) only. In addition,every BMA performed by the site
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bone Marrow Assessment

If clinically indicated, EOT

Bone marrow will be mandatory only if AML relapse is suspected and at the EOT. Every BM assessment performed by local practice must be reported in source documents and in the eCRF.
			Nursing Orders
  	TREATMENT CONDITIONS 4	Interval: --	Occurrences: --	Comments:	If the patient experiences nausea and/or vomiting after the first dose of quizartinib, the participant should receive antiemetics as clinically indicated prior to and after administration of quizartinib. 
Provider should be contacted to send scripts for antiemetics, if warranted.
			Nursing Orders
  	TREATMENT CONDITIONS 4	Interval: --	Occurrences: --	Comments:	If the patients QTc is >480 ms, notify provider
			Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Patients will be started on quizartinib 30 mg once daily for all days.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Quizartinib 30 mg PO once daily
				Day 21	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	Interval: --	Occurrences: --	Comments:	If screening assessment was performed within 3 days of the first dose, it does not need to be repeated.
Vital signs will include the measurements of respiratory rate, heart rate, systolic and diastolic blood pressures, temperature, and body weight. Blood pressure and pulse rate will be measured after the participant has rested in a recumbent position for 5 minutes or more and prior to laboratory draws
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	AEs/SAEs

Only non-serious AEs related to protocol specified procedure or intervention or any SAE should be
reported after ICF, but before first dose of quizartinib.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/
Concomitant
Therapies

Specific induction and consolidation chemotherapy regimens used must be recorded.
The use of FLT3 inhibitors during induction
and consolidation must be precisely recorded, including information about the administration of midostaurin, quizartinib, other FLT3 inhibitors or none.
			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: --			Pharmacokinetic Instructions
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	PK blood sampling times -0.5 to
0 hours (predose) on C1D1, C1D15,
and C2D1, and 2 to 4 hours (postdose)
on C1D1, C1D8, C1D15, C1D21
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	FACIT-GP5

The pretreatment (baseline) PRO assessment is to be administered before the participant has knowledge of the treatment assignment PROs are to be administered to the participant prior to any other assessments.
FACIT-GP5 is to be administered from C1D8 onward.
Have a 40-hour window before the due date.
C15 - C36 assessment window will be +/- 2 days in relation to CxD1
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PRO-CTCAE

Have a 40-hour window before the due date.
C15 - C36 assessment window will be +/- 2 days in relation to CxD1
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Response/
Relapse
Assessment

based on local assessments using local hematology laboratory performed every month during the first 12 cycles of quizartinib maintenance as single agent
and every 3 months during the second and third year of maintenance. In case of abnormal CBC results suspicious of relapse, a bone marrow assessment and
CBC with manual differential should be performed and response assessment should be reported in the source
document and eCRF with date of relapse documented in the eCRF. Mandatory bone marrow assessments
are required at Screening, at the end of treatment (EOT) only. In addition,every BMA performed by the site
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bone Marrow Assessment

If clinically indicated, EOT

Bone marrow will be mandatory only if AML relapse is suspected and at the EOT. Every BM assessment performed by local practice must be reported in source documents and in the eCRF.
			Nursing Orders
  	TREATMENT CONDITIONS 4	Interval: --	Occurrences: --	Comments:	If the patient experiences nausea and/or vomiting after the first dose of quizartinib, the participant should receive antiemetics as clinically indicated prior to and after administration of quizartinib. 
Provider should be contacted to send scripts for antiemetics, if warranted.
			Nursing Orders
  	TREATMENT CONDITIONS 4	Interval: --	Occurrences: --	Comments:	If the patients QTc is >480 ms, notify provider
			Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Patients will be started on quizartinib 30 mg once daily for all days.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Quizartinib 30 mg PO once daily
					
Cycle 2	Repeat 1 time	Cycle length: 28 days	Day 1	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	Interval: --	Occurrences: --	Comments:	If screening assessment was performed within 3 days of the first dose, it does not need to be repeated.
Vital signs will include the measurements of respiratory rate, heart rate, systolic and diastolic blood pressures, temperature, and body weight. Blood pressure and pulse rate will be measured after the participant has rested in a recumbent position for 5 minutes or more and prior to laboratory draws
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please follow the order: vital signs, blood draws, and treatment.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG PS
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	AEs/SAEs

Only non-serious AEs related to protocol specified procedure or intervention or any SAE should be
reported after ICF, but before first dose of quizartinib.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/
Concomitant
Therapies

Specific induction and consolidation chemotherapy regimens used must be recorded.
The use of FLT3 inhibitors during induction
and consolidation must be precisely recorded, including information about the administration of midostaurin, quizartinib, other FLT3 inhibitors or none.
			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: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Pharmacokinetic Instructions
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	PK blood sampling times -0.5 to
0 hours (predose) on C1D1, C1D15,
and C2D1, and 2 to 4 hours (postdose)
on C1D1, C1D8, C1D15, C1D21
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ePRO mobile
application
setup, device
allocation,
Training

ePRO application setup on participant's personal device (phone/tablet) or provisioned handheld (if participant
does not own suitable device)
Training to be administered before any other assessments 

modules
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	EORTC
QLQ-C30
Modules

The pretreatment (baseline) PRO
assessment is to be administered before
the participant has knowledge of the
treatment assignment.
PROs are to be administered to the
participant prior to any other
assessments.
3 C15 - C36 assessment window will be
+/- 2 days in relation to CxD1
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	FACIT-GP5

The pretreatment (baseline) PRO assessment is to be administered before the participant has knowledge of the treatment assignment PROs are to be administered to the participant prior to any other assessments.
FACIT-GP5 is to be administered from C1D8 onward.
Have a 40-hour window before the due date.
C15 - C36 assessment window will be +/- 2 days in relation to CxD1
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PRO-CTCAE

Have a 40-hour window before the due date.
C15 - C36 assessment window will be +/- 2 days in relation to CxD1
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Response/
Relapse
Assessment

based on local assessments using local hematology laboratory performed every month during the first 12 cycles of quizartinib maintenance as single agent
and every 3 months during the second and third year of maintenance. In case of abnormal CBC results suspicious of relapse, a bone marrow assessment and
CBC with manual differential should be performed and response assessment should be reported in the source
document and eCRF with date of relapse documented in the eCRF. Mandatory bone marrow assessments
are required at Screening, at the end of treatment (EOT) only. In addition,every BMA performed by the site
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bone Marrow Assessment

If clinically indicated, EOT

Bone marrow will be mandatory only if AML relapse is suspected and at the EOT. Every BM assessment performed by local practice must be reported in source documents and in the eCRF.
			Nursing Orders
  	TREATMENT CONDITIONS 4	Interval: --	Occurrences: --	Comments:	If the patient experiences nausea and/or vomiting after the first dose of quizartinib, the participant should receive antiemetics as clinically indicated prior to and after administration of quizartinib. 
Provider should be contacted to send scripts for antiemetics, if warranted.
			Nursing Orders
  	TREATMENT CONDITIONS 4	Interval: --	Occurrences: --	Comments:	If the patients QTc is >480 ms, notify provider
			Nursing Orders
  	TREATMENT CONDITIONS 4	Interval: --	Occurrences: --	Comments:	If potassium is LESS THAN 3 mmol/L, notify provider
If magnesium is LESS THAN 0.9 mg/dL, notify provider
		  	TREATMENT CONDITIONS 4	Interval: --	Occurrences: --	Comments:	If AST or ALT is GREATER than >5 × ULN, notify provider
If total bilirubin is GREATER THAN 3 × ULN, notify provider
			Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Patients will be started on quizartinib 30 mg once daily for days 1-15 and then escalated to 60 mg/day orally once daily on C1D16 if QTcF <=450 ms
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	quizartinib 30 mg PO once daily for days 1-15
				Day 8	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	Interval: --	Occurrences: --	Comments:	If screening assessment was performed within 3 days of the first dose, it does not need to be repeated.
Vital signs will include the measurements of respiratory rate, heart rate, systolic and diastolic blood pressures, temperature, and body weight. Blood pressure and pulse rate will be measured after the participant has rested in a recumbent position for 5 minutes or more and prior to laboratory draws
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	AEs/SAEs

Only non-serious AEs related to protocol specified procedure or intervention or any SAE should be
reported after ICF, but before first dose of quizartinib.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/
Concomitant
Therapies

Specific induction and consolidation chemotherapy regimens used must be recorded.
The use of FLT3 inhibitors during induction
and consolidation must be precisely recorded, including information about the administration of midostaurin, quizartinib, other FLT3 inhibitors or none.
			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: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	FACIT-GP5

The pretreatment (baseline) PRO assessment is to be administered before the participant has knowledge of the treatment assignment PROs are to be administered to the participant prior to any other assessments.
FACIT-GP5 is to be administered from C1D8 onward.
Have a 40-hour window before the due date.
C15 - C36 assessment window will be +/- 2 days in relation to CxD1
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PRO-CTCAE

Have a 40-hour window before the due date.
C15 - C36 assessment window will be +/- 2 days in relation to CxD1
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Response/
Relapse
Assessment

based on local assessments using local hematology laboratory performed every month during the first 12 cycles of quizartinib maintenance as single agent
and every 3 months during the second and third year of maintenance. In case of abnormal CBC results suspicious of relapse, a bone marrow assessment and
CBC with manual differential should be performed and response assessment should be reported in the source
document and eCRF with date of relapse documented in the eCRF. Mandatory bone marrow assessments
are required at Screening, at the end of treatment (EOT) only. In addition,every BMA performed by the site
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bone Marrow Assessment

If clinically indicated, EOT

Bone marrow will be mandatory only if AML relapse is suspected and at the EOT. Every BM assessment performed by local practice must be reported in source documents and in the eCRF.
			Nursing Orders
  	TREATMENT CONDITIONS 4	Interval: --	Occurrences: --	Comments:	If the patient experiences nausea and/or vomiting after the first dose of quizartinib, the participant should receive antiemetics as clinically indicated prior to and after administration of quizartinib. 
Provider should be contacted to send scripts for antiemetics, if warranted.
			Nursing Orders
  	TREATMENT CONDITIONS 4	Interval: --	Occurrences: --	Comments:	If the patients QTc is >480 ms, notify provider
			Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Patients will be started on quizartinib 30 mg once daily for days 1-15 and then escalated to 60 mg/day orally once daily on C1D16 if QTcF <=450 ms
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	quizartinib 30 mg PO once daily for days 1-15
				Day 15	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	Interval: --	Occurrences: --	Comments:	If screening assessment was performed within 3 days of the first dose, it does not need to be repeated.
Vital signs will include the measurements of respiratory rate, heart rate, systolic and diastolic blood pressures, temperature, and body weight. Blood pressure and pulse rate will be measured after the participant has rested in a recumbent position for 5 minutes or more and prior to laboratory draws
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	AEs/SAEs

Only non-serious AEs related to protocol specified procedure or intervention or any SAE should be
reported after ICF, but before first dose of quizartinib.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/
Concomitant
Therapies

Specific induction and consolidation chemotherapy regimens used must be recorded.
The use of FLT3 inhibitors during induction
and consolidation must be precisely recorded, including information about the administration of midostaurin, quizartinib, other FLT3 inhibitors or none.
			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: --			Pharmacokinetic Instructions
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	PK blood sampling times -0.5 to
0 hours (predose) on C1D1, C1D15,
and C2D1, and 2 to 4 hours (postdose)
on C1D1, C1D8, C1D15, C1D21
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	FACIT-GP5

The pretreatment (baseline) PRO assessment is to be administered before the participant has knowledge of the treatment assignment PROs are to be administered to the participant prior to any other assessments.
FACIT-GP5 is to be administered from C1D8 onward.
Have a 40-hour window before the due date.
C15 - C36 assessment window will be +/- 2 days in relation to CxD1
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PRO-CTCAE

Have a 40-hour window before the due date.
C15 - C36 assessment window will be +/- 2 days in relation to CxD1
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Response/
Relapse
Assessment

based on local assessments using local hematology laboratory performed every month during the first 12 cycles of quizartinib maintenance as single agent
and every 3 months during the second and third year of maintenance. In case of abnormal CBC results suspicious of relapse, a bone marrow assessment and
CBC with manual differential should be performed and response assessment should be reported in the source
document and eCRF with date of relapse documented in the eCRF. Mandatory bone marrow assessments
are required at Screening, at the end of treatment (EOT) only. In addition,every BMA performed by the site
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bone Marrow Assessment

If clinically indicated, EOT

Bone marrow will be mandatory only if AML relapse is suspected and at the EOT. Every BM assessment performed by local practice must be reported in source documents and in the eCRF.
			Nursing Orders
  	TREATMENT CONDITIONS 4	Interval: --	Occurrences: --	Comments:	If the patient experiences nausea and/or vomiting after the first dose of quizartinib, the participant should receive antiemetics as clinically indicated prior to and after administration of quizartinib. 
Provider should be contacted to send scripts for antiemetics, if warranted.
			Nursing Orders
  	TREATMENT CONDITIONS 4	Interval: --	Occurrences: --	Comments:	If the patients QTc is >480 ms, notify provider
			Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Patients will be started on quizartinib 30 mg once daily for days 1-15 and then escalated to 60 mg/day orally once daily on C1D16 if QTcF <=450 ms
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	quizartinib 30 mg PO once daily for days 1-15
				Day 21	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	Interval: --	Occurrences: --	Comments:	If screening assessment was performed within 3 days of the first dose, it does not need to be repeated.
Vital signs will include the measurements of respiratory rate, heart rate, systolic and diastolic blood pressures, temperature, and body weight. Blood pressure and pulse rate will be measured after the participant has rested in a recumbent position for 5 minutes or more and prior to laboratory draws
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	AEs/SAEs

Only non-serious AEs related to protocol specified procedure or intervention or any SAE should be
reported after ICF, but before first dose of quizartinib.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/
Concomitant
Therapies

Specific induction and consolidation chemotherapy regimens used must be recorded.
The use of FLT3 inhibitors during induction
and consolidation must be precisely recorded, including information about the administration of midostaurin, quizartinib, other FLT3 inhibitors or none.
			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: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	FACIT-GP5

The pretreatment (baseline) PRO assessment is to be administered before the participant has knowledge of the treatment assignment PROs are to be administered to the participant prior to any other assessments.
FACIT-GP5 is to be administered from C1D8 onward.
Have a 40-hour window before the due date.
C15 - C36 assessment window will be +/- 2 days in relation to CxD1
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PRO-CTCAE

Have a 40-hour window before the due date.
C15 - C36 assessment window will be +/- 2 days in relation to CxD1
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Response/
Relapse
Assessment

based on local assessments using local hematology laboratory performed every month during the first 12 cycles of quizartinib maintenance as single agent
and every 3 months during the second and third year of maintenance. In case of abnormal CBC results suspicious of relapse, a bone marrow assessment and
CBC with manual differential should be performed and response assessment should be reported in the source
document and eCRF with date of relapse documented in the eCRF. Mandatory bone marrow assessments
are required at Screening, at the end of treatment (EOT) only. In addition,every BMA performed by the site
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bone Marrow Assessment

If clinically indicated, EOT

Bone marrow will be mandatory only if AML relapse is suspected and at the EOT. Every BM assessment performed by local practice must be reported in source documents and in the eCRF.
			Nursing Orders
  	TREATMENT CONDITIONS 4	Interval: --	Occurrences: --	Comments:	If the patient experiences nausea and/or vomiting after the first dose of quizartinib, the participant should receive antiemetics as clinically indicated prior to and after administration of quizartinib. 
Provider should be contacted to send scripts for antiemetics, if warranted.
			Nursing Orders
  	TREATMENT CONDITIONS 4	Interval: --	Occurrences: --	Comments:	If the patients QTc is >480 ms, notify provider
			Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Patients will be started on quizartinib 30 mg once daily for all days.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Quizartinib 30 mg PO once daily
					
Cycles 3 to 12	Repeat 10 times	Cycle length: 28 days	Day 1	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	Interval: --	Occurrences: --	Comments:	If screening assessment was performed within 3 days of the first dose, it does not need to be repeated.
Vital signs will include the measurements of respiratory rate, heart rate, systolic and diastolic blood pressures, temperature, and body weight. Blood pressure and pulse rate will be measured after the participant has rested in a recumbent position for 5 minutes or more and prior to laboratory draws
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please follow the order: vital signs, blood draws, and treatment.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG PS
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	AEs/SAEs

Only non-serious AEs related to protocol specified procedure or intervention or any SAE should be
reported after ICF, but before first dose of quizartinib.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/
Concomitant
Therapies

Specific induction and consolidation chemotherapy regimens used must be recorded.
The use of FLT3 inhibitors during induction
and consolidation must be precisely recorded, including information about the administration of midostaurin, quizartinib, other FLT3 inhibitors or none.
			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: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Pharmacokinetic Instructions
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	PK blood sampling times -0.5 to
0 hours (predose) on C1D1, C1D15,
and C2D1, and 2 to 4 hours (postdose)
on C1D1, C1D8, C1D15, C1D21
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ePRO mobile
application
setup, device
allocation,
Training

ePRO application setup on participant's personal device (phone/tablet) or provisioned handheld (if participant
does not own suitable device)
Training to be administered before any other assessments 

modules
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	EORTC
QLQ-C30
Modules

The pretreatment (baseline) PRO
assessment is to be administered before
the participant has knowledge of the
treatment assignment.
PROs are to be administered to the
participant prior to any other
assessments.
3 C15 - C36 assessment window will be
+/- 2 days in relation to CxD1
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	FACIT-GP5

The pretreatment (baseline) PRO assessment is to be administered before the participant has knowledge of the treatment assignment PROs are to be administered to the participant prior to any other assessments.
FACIT-GP5 is to be administered from C1D8 onward.
Have a 40-hour window before the due date.
C15 - C36 assessment window will be +/- 2 days in relation to CxD1
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PRO-CTCAE

Have a 40-hour window before the due date.
C15 - C36 assessment window will be +/- 2 days in relation to CxD1
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Response/
Relapse
Assessment

based on local assessments using local hematology laboratory performed every month during the first 12 cycles of quizartinib maintenance as single agent
and every 3 months during the second and third year of maintenance. In case of abnormal CBC results suspicious of relapse, a bone marrow assessment and
CBC with manual differential should be performed and response assessment should be reported in the source
document and eCRF with date of relapse documented in the eCRF. Mandatory bone marrow assessments
are required at Screening, at the end of treatment (EOT) only. In addition,every BMA performed by the site
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bone Marrow Assessment

If clinically indicated, EOT

Bone marrow will be mandatory only if AML relapse is suspected and at the EOT. Every BM assessment performed by local practice must be reported in source documents and in the eCRF.
			Nursing Orders
  	TREATMENT CONDITIONS 4	Interval: --	Occurrences: --	Comments:	If the patient experiences nausea and/or vomiting after the first dose of quizartinib, the participant should receive antiemetics as clinically indicated prior to and after administration of quizartinib. 
Provider should be contacted to send scripts for antiemetics, if warranted.
			Nursing Orders
  	TREATMENT CONDITIONS 4	Interval: --	Occurrences: --	Comments:	If the patients QTc is >480 ms, notify provider
			Nursing Orders
  	TREATMENT CONDITIONS 4	Interval: --	Occurrences: --	Comments:	If potassium is LESS THAN 3 mmol/L, notify provider
If magnesium is LESS THAN 0.9 mg/dL, notify provider
		  	TREATMENT CONDITIONS 4	Interval: --	Occurrences: --	Comments:	If AST or ALT is GREATER than >5 × ULN, notify provider
If total bilirubin is GREATER THAN 3 × ULN, notify provider
			Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Patients will be started on quizartinib 30 mg once daily for all days.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Quizartinib 30 mg PO once daily
					
C15, C18, C21, C24, C27, C30, C33, C36	Repeat 8 times	Cycle length: 28 days	Day 1	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	Interval: --	Occurrences: --	Comments:	If screening assessment was performed within 3 days of the first dose, it does not need to be repeated.
Vital signs will include the measurements of respiratory rate, heart rate, systolic and diastolic blood pressures, temperature, and body weight. Blood pressure and pulse rate will be measured after the participant has rested in a recumbent position for 5 minutes or more and prior to laboratory draws
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please follow the order: vital signs, blood draws, and treatment.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG PS
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	AEs/SAEs

Only non-serious AEs related to protocol specified procedure or intervention or any SAE should be
reported after ICF, but before first dose of quizartinib.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/
Concomitant
Therapies

Specific induction and consolidation chemotherapy regimens used must be recorded.
The use of FLT3 inhibitors during induction
and consolidation must be precisely recorded, including information about the administration of midostaurin, quizartinib, other FLT3 inhibitors or none.
			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: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Pharmacokinetic Instructions
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	PK blood sampling times -0.5 to
0 hours (predose) on C1D1, C1D15,
and C2D1, and 2 to 4 hours (postdose)
on C1D1, C1D8, C1D15, C1D21
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	EORTC
QLQ-C30
Modules

The pretreatment (baseline) PRO
assessment is to be administered before
the participant has knowledge of the
treatment assignment.
PROs are to be administered to the
participant prior to any other
assessments.
3 C15 - C36 assessment window will be
+/- 2 days in relation to CxD1
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	FACIT-GP5

The pretreatment (baseline) PRO assessment is to be administered before the participant has knowledge of the treatment assignment PROs are to be administered to the participant prior to any other assessments.
FACIT-GP5 is to be administered from C1D8 onward.
Have a 40-hour window before the due date.
C15 - C36 assessment window will be +/- 2 days in relation to CxD1
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PRO-CTCAE

Have a 40-hour window before the due date.
C15 - C36 assessment window will be +/- 2 days in relation to CxD1
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Response/
Relapse
Assessment

based on local assessments using local hematology laboratory performed every month during the first 12 cycles of quizartinib maintenance as single agent
and every 3 months during the second and third year of maintenance. In case of abnormal CBC results suspicious of relapse, a bone marrow assessment and
CBC with manual differential should be performed and response assessment should be reported in the source
document and eCRF with date of relapse documented in the eCRF. Mandatory bone marrow assessments
are required at Screening, at the end of treatment (EOT) only. In addition,every BMA performed by the site
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bone Marrow Assessment

If clinically indicated, EOT

Bone marrow will be mandatory only if AML relapse is suspected and at the EOT. Every BM assessment performed by local practice must be reported in source documents and in the eCRF.
			Nursing Orders
  	TREATMENT CONDITIONS 4	Interval: --	Occurrences: --	Comments:	If the patient experiences nausea and/or vomiting after the first dose of quizartinib, the participant should receive antiemetics as clinically indicated prior to and after administration of quizartinib. 
Provider should be contacted to send scripts for antiemetics, if warranted.
			Nursing Orders
  	TREATMENT CONDITIONS 4	Interval: --	Occurrences: --	Comments:	If the patients QTc is >480 ms, notify provider
			Nursing Orders
  	TREATMENT CONDITIONS 4	Interval: --	Occurrences: --	Comments:	If potassium is LESS THAN 3 mmol/L, notify provider
If magnesium is LESS THAN 0.9 mg/dL, notify provider
		  	TREATMENT CONDITIONS 4	Interval: --	Occurrences: --	Comments:	If AST or ALT is GREATER than >5 × ULN, notify provider
If total bilirubin is GREATER THAN 3 × ULN, notify provider
			Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Patients will be started on quizartinib 30 mg once daily for all days.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Quizartinib 30 mg PO once daily
					
EOT	Repeat 1 time	Cycle length: 7 days	Day 1	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	Interval: --	Occurrences: --	Comments:	If screening assessment was performed within 3 days of the first dose, it does not need to be repeated.
Vital signs will include the measurements of respiratory rate, heart rate, systolic and diastolic blood pressures, temperature, and body weight. Blood pressure and pulse rate will be measured after the participant has rested in a recumbent position for 5 minutes or more and prior to laboratory draws
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please follow the order: vital signs, blood draws, and treatment.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG PS
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	AEs/SAEs

Only non-serious AEs related to protocol specified procedure or intervention or any SAE should be
reported after ICF, but before first dose of quizartinib.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/
Concomitant
Therapies

Specific induction and consolidation chemotherapy regimens used must be recorded.
The use of FLT3 inhibitors during induction
and consolidation must be precisely recorded, including information about the administration of midostaurin, quizartinib, other FLT3 inhibitors or none.
			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: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	EORTC
QLQ-C30
Modules

The pretreatment (baseline) PRO
assessment is to be administered before
the participant has knowledge of the
treatment assignment.
PROs are to be administered to the
participant prior to any other
assessments.
3 C15 - C36 assessment window will be
+/- 2 days in relation to CxD1
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	FACIT-GP5

The pretreatment (baseline) PRO assessment is to be administered before the participant has knowledge of the treatment assignment PROs are to be administered to the participant prior to any other assessments.
FACIT-GP5 is to be administered from C1D8 onward.
Have a 40-hour window before the due date.
C15 - C36 assessment window will be +/- 2 days in relation to CxD1
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PRO-CTCAE

Have a 40-hour window before the due date.
C15 - C36 assessment window will be +/- 2 days in relation to CxD1
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Response/
Relapse
Assessment

based on local assessments using local hematology laboratory performed every month during the first 12 cycles of quizartinib maintenance as single agent
and every 3 months during the second and third year of maintenance. In case of abnormal CBC results suspicious of relapse, a bone marrow assessment and
CBC with manual differential should be performed and response assessment should be reported in the source
document and eCRF with date of relapse documented in the eCRF. Mandatory bone marrow assessments
are required at Screening, at the end of treatment (EOT) only. In addition,every BMA performed by the site
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Bone Marrow Assessment

If clinically indicated, EOT

Bone marrow will be mandatory only if AML relapse is suspected and at the EOT. Every BM assessment performed by local practice must be reported in source documents and in the eCRF.
					
SFU	Repeat 1 time	Cycle length: 30 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	If screening assessment was performed within 3 days of the first dose, it does not need to be repeated.
Vital signs will include the measurements of respiratory rate, heart rate, systolic and diastolic blood pressures, temperature, and body weight. Blood pressure and pulse rate will be measured after the participant has rested in a recumbent position for 5 minutes or more and prior to laboratory draws
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please follow the order: vital signs, blood draws, and treatment.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG PS
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	AEs/SAEs

Only non-serious AEs related to protocol specified procedure or intervention or any SAE should be
reported after ICF, but before first dose of quizartinib.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/
Concomitant
Therapies

Specific induction and consolidation chemotherapy regimens used must be recorded.
The use of FLT3 inhibitors during induction
and consolidation must be precisely recorded, including information about the administration of midostaurin, quizartinib, other FLT3 inhibitors or none.
			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: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	EORTC
QLQ-C30
Modules

The pretreatment (baseline) PRO
assessment is to be administered before
the participant has knowledge of the
treatment assignment.
PROs are to be administered to the
participant prior to any other
assessments.
3 C15 - C36 assessment window will be
+/- 2 days in relation to CxD1
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	FACIT-GP5

The pretreatment (baseline) PRO assessment is to be administered before the participant has knowledge of the treatment assignment PROs are to be administered to the participant prior to any other assessments.
FACIT-GP5 is to be administered from C1D8 onward.
Have a 40-hour window before the due date.
C15 - C36 assessment window will be +/- 2 days in relation to CxD1
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PRO-CTCAE

Have a 40-hour window before the due date.
C15 - C36 assessment window will be +/- 2 days in relation to CxD1
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Subsequent
Anticancer
Treatment
					
LTFU	Repeat 1 time	Cycle length: 90 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please follow the order: vital signs, blood draws, and treatment.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG PS
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	AEs/SAEs

Only non-serious AEs related to protocol specified procedure or intervention or any SAE should be
reported after ICF, but before first dose of quizartinib.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/
Concomitant
Therapies

Specific induction and consolidation chemotherapy regimens used must be recorded.
The use of FLT3 inhibitors during induction
and consolidation must be precisely recorded, including information about the administration of midostaurin, quizartinib, other FLT3 inhibitors or none.
			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
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Subsequent
Anticancer
Treatment
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Survival FU

Assess at least every 3 months (±14 days) until trial completion, withdrawal of consent, lost to follow-up, or death.