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IP/OP RESEARCH PRO00038439 / AC220-168 PLAN E: CONSOLIDATION	

Types:      Research Oncology Treatment
Synonyms:  PLAN E

Cycle 1	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			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:	Randomization
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Eligibility Assessments
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Physical examination should be performed on the same date as the bone marrow aspiration
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	OP RSH PRO00038439 / AC220-168 EORTC QLQC30, PGI-S, EQ- 5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PGI-C
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	IL46
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Starting on Day 21, should be collected at least weekly until counts have recovered. After counts have recovered beyond Day 21, hematology assessment should be collected only on date of bone marrow aspiration
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	GGT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LDH	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Only as needed (eg, if renal function has decreased).
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of childbearing potential
			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Urine or serum. For women of childbearing potential
			Procedures
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
			Pre-Medications
  	ondansetron/dexAMETHasone 16 mg/12 mg in NS 50 mL IVPB	Dose: 50 mL	Route: intravenous	once @ 200 mL/hr over 15 Minutes for 1 dose	Start: S					Chemotherapy
  	cytarabine PF (CYSTOSAR) 3 g/m2 in dextrose 5% 500 mL chemo IVPB	Dose: 3 g/m2	Route: intravenous	every 12 hours over 180 Minutes for 2 doses			Offset: 30 Minutes	Instructions:	For participants <60 years old: cytarabine 3.0 g/m2 IV; 
For participants >=60 years old: cytarabine 1.5 g/m2 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CYTARABINE (PF) 2 GRAM/20 ML (100 MG/ML) INJECTION SOLUTION	Medications	3 g/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	500 mL	No	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	500 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: Until discontinued	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: Until discontinued	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: Until discontinued	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN	Start: S				  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
				Day 2 - Day of Rest	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	Interval: --	Occurrences: --	Comments:	Day of Rest
				Day 3	Perform every 1 day x1			Research tolerance: -0/+0 days	Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			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
			Pre-Medications
  	ondansetron/dexAMETHasone 16 mg/12 mg in NS 50 mL IVPB	Dose: 50 mL	Route: intravenous	once @ 200 mL/hr over 15 Minutes for 1 dose	Start: S					Chemotherapy
  	cytarabine PF (CYSTOSAR) 3 g/m2 in dextrose 5% 500 mL chemo IVPB	Dose: 3 g/m2	Route: intravenous	every 12 hours over 180 Minutes for 2 doses			Offset: 30 Minutes	Instructions:	For participants <60 years old: cytarabine 3.0 g/m2 IV; 
For participants >=60 years old: cytarabine 1.5 g/m2 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CYTARABINE (PF) 2 GRAM/20 ML (100 MG/ML) INJECTION SOLUTION	Medications	3 g/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	500 mL	No	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	500 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: Until discontinued	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: Until discontinued	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: Until discontinued	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN	Start: S				  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S						Day 4 - Day of Rest	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	Interval: --	Occurrences: --	Comments:	Day of Rest
				Day 5	Perform every 1 day x1			Research tolerance: -0/+0 days	Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			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
			Pre-Medications
  	ondansetron/dexAMETHasone 16 mg/12 mg in NS 50 mL IVPB	Dose: 50 mL	Route: intravenous	once @ 200 mL/hr over 15 Minutes for 1 dose	Start: S					Chemotherapy
  	cytarabine PF (CYSTOSAR) 3 g/m2 in dextrose 5% 500 mL chemo IVPB	Dose: 3 g/m2	Route: intravenous	every 12 hours over 180 Minutes for 2 doses			Offset: 30 Minutes	Instructions:	For participants <60 years old: cytarabine 3.0 g/m2 IV; 
For participants >=60 years old: cytarabine 1.5 g/m2 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CYTARABINE (PF) 2 GRAM/20 ML (100 MG/ML) INJECTION SOLUTION	Medications	3 g/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	500 mL	No	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	500 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: Until discontinued	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: Until discontinued	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: Until discontinued	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN	Start: S				  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S						Day 6	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
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Quizartinib/placebo will be administered at 60 mg orally once daily for 14 consecutive days, starting on Day 6
			Nursing Orders
☑	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Quizartinib Placebo Dispensation from IRT.Where feasible, IRT dispensation and quizartinib/placebo administration should occur on the same day. A -3 day window between IRT dispensation and actual drug administration is permissible if logistically necessary (e.g. investigational pharmacy closures on weekends and holidays). Actual administration is to be recorded in EDC
		☑	INV-QUIZARTINIB/PLACEBO 20 MG (ACC220-168/PRO00038439/SHAH) TABLET	Dose: --	Route: oral	daily	Start: S			Instructions:	Hazardous.  Take by mouth once daily with or without food for 14 consecutive days starting from D8 during induction and from D6 during consolidation, then continuous dosing for 36 cycles, 28 days per cycle.  Take at the same time each day. Do not crush or cut tablets for oral administration.  For NG: crush and mixh with 10mL of water per tablet.		☑	INV-QUIZARTINIB/PLACEBO 30 MG (ACC220-168/PRO00038439/SHAH) TABLET	Dose: --	Route: oral	once for 1 dose	Start: S			Instructions:	Hazardous.  Take by mouth once daily with or without food for 14 consecutive days starting from D8 during induction and from D6 during consolidation, then continuous dosing for 36 cycles, 28 days per cycle.  Take at the same time each day. Do not crush or cut tablets for oral administration.  For NG: crush and mixh with 10mL of water per tablet.			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Starting on Day 21, should be collected at least weekly until counts have recovered. After counts have recovered beyond Day 21, hematology assessment should be collected only on date of bone marrow aspiration
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	GGT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LDH	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect blood samples for PK within 10 minutes after last triplicate ECG. For specific times, see Table 8.3.
			Procedures
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
				Day 7	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:	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 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
				Day 8	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
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	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 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
				Day 9	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	Interval: --	Occurrences: --	Comments:	Day of Rest
				Day 13	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
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	IL46
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PGI-C
			Procedures
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Starting on Day 21, should be collected at least weekly until counts have recovered. After counts have recovered beyond Day 21, hematology assessment should be collected only on date of bone marrow aspiration
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	GGT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LDH	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect blood samples for PK within 10 minutes after last triplicate ECG. For specific times, see Table 8.3.
				Day 15	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:	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 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
				Day 19	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	Interval: --	Occurrences: --	Comments:	Collect Quizartinib/Placebo Returned/Assess Treatment Compliance
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Starting on Day 21, should be collected at least weekly until counts have recovered. After counts have recovered beyond Day 21, hematology assessment should be collected only on date of bone marrow aspiration
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	GGT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LDH	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect blood samples for PK within 10 minutes after last triplicate ECG. For specific times, see Table 8.3.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Only collected for participants undergoing intensive PK in the PK-ECG Sub-study. When collected at the same schedule time as PK samples, PIA samples will be collected immediately after PK samples. Pre-dose and 4 hours post-dose.
			Procedures
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
				Day 21	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
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	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 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Physical examination should be performed on the same date as the bone marrow aspiration
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Response assessment to : Response assessment will be based on local assessments (BMA or
biopsy/CBC/physical examination to assess for signs and symptoms of extramedullary disease) using the response criteria as defined in Table 8.1. IRC will retrospectively review local assessments to determine response. If the bone marrow assessment is consistent with remission but peripheral blood counts are not recovered within 14 days of the
initial sample for response assessment, a repeat bone marrow examination is required for remission assessment at the time of count recovery.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Local and Central Bone Marrow Collection : Collect bone marrow sample upon count recovery but no later than Day 42. If counts have not recovered, a bone marrow sample must be performed by Day 42. It is not recommended to perform an aplasia assessment of response prior to Day 21. If the bone marrow assessment is consistent with remission but peripheral blood counts are not recovered within 14 days of the initial sample for response assessment, a repeat bone marrow sample is required at the time of count recovery.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	FLTD3-ITD NGS:  Collect at end of Induction at same time as bone marrow assessment.
			Nursing Orders
  	ONC NURSING COMMUNICATION	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.
			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.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	GGT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LDH	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
				Day 22	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:	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 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	FLTD3-ITD NGS:  Collect at end of Induction at same time as bone marrow assessment.
			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.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
				Day 23	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
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
				Day 24	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
				Day 25	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
				Day 26	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
				Day 27	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
				Day 28	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
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	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 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Physical examination should be performed on the same date as the bone marrow aspiration
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Response assessment to : Response assessment will be based on local assessments (BMA or
biopsy/CBC/physical examination to assess for signs and symptoms of extramedullary disease) using the response criteria as defined in Table 8.1. IRC will retrospectively review local assessments to determine response. If the bone marrow assessment is consistent with remission but peripheral blood counts are not recovered within 14 days of the
initial sample for response assessment, a repeat bone marrow examination is required for remission assessment at the time of count recovery.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Local and Central Bone Marrow Collection : Collect bone marrow sample upon count recovery but no later than Day 42. If counts have not recovered, a bone marrow sample must be performed by Day 42. It is not recommended to perform an aplasia assessment of response prior to Day 21. If the bone marrow assessment is consistent with remission but peripheral blood counts are not recovered within 14 days of the initial sample for response assessment, a repeat bone marrow sample is required at the time of count recovery.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	FLTD3-ITD NGS:  Collect at end of Induction at same time as bone marrow assessment.
			Nursing Orders
  	ONC NURSING COMMUNICATION	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.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	OP RSH PRO00038439 / AC220-168 EORTC QLQC30, PGI-S, EQ- 5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	IL46
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PGI-C
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Healthcare Resource Authorization
			Procedures
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	GGT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LDH	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
			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.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
					
Cycle 2	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			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
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	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 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Physical examination should be performed on the same date as the bone marrow aspiration
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	OP RSH PRO00038439 / AC220-168 EORTC QLQC30, PGI-S, EQ- 5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	IL46
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PGI-C
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Procedures
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Starting on Day 21, should be collected at least weekly until counts have recovered. After counts have recovered beyond Day 21, hematology assessment should be collected only on date of bone marrow aspiration
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	GGT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LDH	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Only as needed (eg, if renal function has decreased).
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of childbearing potential
			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Urine or serum. For women of childbearing potential
			Pre-Medications
  	ondansetron/dexAMETHasone 16 mg/12 mg in NS 50 mL IVPB	Dose: 50 mL	Route: intravenous	once @ 200 mL/hr over 15 Minutes for 1 dose	Start: S					Chemotherapy
  	cytarabine PF (CYSTOSAR) 3 g/m2 in dextrose 5% 500 mL chemo IVPB	Dose: 3 g/m2	Route: intravenous	every 12 hours over 180 Minutes for 2 doses			Offset: 30 Minutes	Instructions:	For participants <60 years old: cytarabine 3.0 g/m2 IV; 
For participants >=60 years old: cytarabine 1.5 g/m2 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CYTARABINE (PF) 2 GRAM/20 ML (100 MG/ML) INJECTION SOLUTION	Medications	3 g/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	500 mL	No	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	500 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: Until discontinued	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: Until discontinued	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: Until discontinued	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN	Start: S				  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
				Day 2 - Day of Rest	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	Interval: --	Occurrences: --	Comments:	Day of Rest
				Day 3	Perform every 1 day x1			Research tolerance: -0/+0 days	Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			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
			Pre-Medications
  	ondansetron/dexAMETHasone 16 mg/12 mg in NS 50 mL IVPB	Dose: 50 mL	Route: intravenous	once @ 200 mL/hr over 15 Minutes for 1 dose	Start: S					Chemotherapy
  	cytarabine PF (CYSTOSAR) 3 g/m2 in dextrose 5% 500 mL chemo IVPB	Dose: 3 g/m2	Route: intravenous	every 12 hours over 180 Minutes for 2 doses			Offset: 30 Minutes	Instructions:	For participants <60 years old: cytarabine 3.0 g/m2 IV; 
For participants >=60 years old: cytarabine 1.5 g/m2 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CYTARABINE (PF) 2 GRAM/20 ML (100 MG/ML) INJECTION SOLUTION	Medications	3 g/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	500 mL	No	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	500 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: Until discontinued	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: Until discontinued	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: Until discontinued	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN	Start: S				  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S						Day 4 - Day of Rest	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	Interval: --	Occurrences: --	Comments:	Day of Rest
				Day 5	Perform every 1 day x1			Research tolerance: -0/+0 days	Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			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
			Pre-Medications
  	ondansetron/dexAMETHasone 16 mg/12 mg in NS 50 mL IVPB	Dose: 50 mL	Route: intravenous	once @ 200 mL/hr over 15 Minutes for 1 dose	Start: S					Chemotherapy
  	cytarabine PF (CYSTOSAR) 3 g/m2 in dextrose 5% 500 mL chemo IVPB	Dose: 3 g/m2	Route: intravenous	every 12 hours over 180 Minutes for 2 doses			Offset: 30 Minutes	Instructions:	For participants <60 years old: cytarabine 3.0 g/m2 IV; 
For participants >=60 years old: cytarabine 1.5 g/m2 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CYTARABINE (PF) 2 GRAM/20 ML (100 MG/ML) INJECTION SOLUTION	Medications	3 g/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	500 mL	No	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	500 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: Until discontinued	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: Until discontinued	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: Until discontinued	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN	Start: S				  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S						Day 6	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
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Quizartinib/placebo will be administered at 60 mg orally once daily for 14 consecutive days, starting on Day 6
			Nursing Orders
☑	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Quizartinib Placebo Dispensation from IRT.Where feasible, IRT dispensation and quizartinib/placebo administration should occur on the same day. A -3 day window between IRT dispensation and actual drug administration is permissible if logistically necessary (e.g. investigational pharmacy closures on weekends and holidays). Actual administration is to be recorded in EDC
		☑	INV-QUIZARTINIB/PLACEBO 20 MG (ACC220-168/PRO00038439/SHAH) TABLET	Dose: --	Route: oral	daily	Start: S			Instructions:	Hazardous.  Take by mouth once daily with or without food for 14 consecutive days starting from D8 during induction and from D6 during consolidation, then continuous dosing for 36 cycles, 28 days per cycle.  Take at the same time each day. Do not crush or cut tablets for oral administration.  For NG: crush and mixh with 10mL of water per tablet.		☑	INV-QUIZARTINIB/PLACEBO 30 MG (ACC220-168/PRO00038439/SHAH) TABLET	Dose: --	Route: oral	once for 1 dose	Start: S			Instructions:	Hazardous.  Take by mouth once daily with or without food for 14 consecutive days starting from D8 during induction and from D6 during consolidation, then continuous dosing for 36 cycles, 28 days per cycle.  Take at the same time each day. Do not crush or cut tablets for oral administration.  For NG: crush and mixh with 10mL of water per tablet.			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Starting on Day 21, should be collected at least weekly until counts have recovered. After counts have recovered beyond Day 21, hematology assessment should be collected only on date of bone marrow aspiration
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	GGT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LDH	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
			Procedures
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
				Day 7 - Day of Rest	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	Interval: --	Occurrences: --	Comments:	Day of Rest
				Day 8	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
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	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 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
				Day 13	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
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	IL46
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PGI-C
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Starting on Day 21, should be collected at least weekly until counts have recovered. After counts have recovered beyond Day 21, hematology assessment should be collected only on date of bone marrow aspiration
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	GGT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LDH	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
			Procedures
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
				Day 15	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:	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 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
			Procedures
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
				Day 16	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
				Day 17	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
				Day 18	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
				Day 19	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	Interval: --	Occurrences: --	Comments:	Collect Quizartinib/Placebo Returned/Assess Treatment Compliance
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Starting on Day 21, should be collected at least weekly until counts have recovered. After counts have recovered beyond Day 21, hematology assessment should be collected only on date of bone marrow aspiration
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	GGT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LDH	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Only collected for participants undergoing intensive PK in the PK-ECG Sub-study. When collected at the same schedule time as PK samples, PIA samples will be collected immediately after PK samples. Pre-dose and 4 hours post-dose.
			Procedures
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
				Day 20	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
				Day 21	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
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	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 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Physical examination should be performed on the same date as the bone marrow aspiration
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Response assessment to : Response assessment will be based on local assessments (BMA or
biopsy/CBC/physical examination to assess for signs and symptoms of extramedullary disease) using the response criteria as defined in Table 8.1. IRC will retrospectively review local assessments to determine response. If the bone marrow assessment is consistent with remission but peripheral blood counts are not recovered within 14 days of the
initial sample for response assessment, a repeat bone marrow examination is required for remission assessment at the time of count recovery.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Local and Central Bone Marrow Collection : Collect bone marrow sample upon count recovery but no later than Day 42. If counts have not recovered, a bone marrow sample must be performed by Day 42. It is not recommended to perform an aplasia assessment of response prior to Day 21. If the bone marrow assessment is consistent with remission but peripheral blood counts are not recovered within 14 days of the initial sample for response assessment, a repeat bone marrow sample is required at the time of count recovery.
			Nursing Orders
  	ONC NURSING COMMUNICATION	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.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	GGT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LDH	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
				Day 22	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:	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 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
				Day 23	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
				Day 24	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
				Day 25	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
				Day 26	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
				Day 27	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
				Day 28	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
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	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 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Physical examination should be performed on the same date as the bone marrow aspiration
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Response assessment to : Response assessment will be based on local assessments (BMA or
biopsy/CBC/physical examination to assess for signs and symptoms of extramedullary disease) using the response criteria as defined in Table 8.1. IRC will retrospectively review local assessments to determine response. If the bone marrow assessment is consistent with remission but peripheral blood counts are not recovered within 14 days of the
initial sample for response assessment, a repeat bone marrow examination is required for remission assessment at the time of count recovery.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Local and Central Bone Marrow Collection : Collect bone marrow sample upon count recovery but no later than Day 42. If counts have not recovered, a bone marrow sample must be performed by Day 42. It is not recommended to perform an aplasia assessment of response prior to Day 21. If the bone marrow assessment is consistent with remission but peripheral blood counts are not recovered within 14 days of the initial sample for response assessment, a repeat bone marrow sample is required at the time of count recovery.
			Nursing Orders
  	ONC NURSING COMMUNICATION	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.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	OP RSH PRO00038439 / AC220-168 EORTC QLQC30, PGI-S, EQ- 5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	IL46
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PGI-C
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Healthcare Resource Authorization
			Procedures
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	GGT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LDH	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
					
Cycle 3	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			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
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	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 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Physical examination should be performed on the same date as the bone marrow aspiration
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	OP RSH PRO00038439 / AC220-168 EORTC QLQC30, PGI-S, EQ- 5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	IL46
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PGI-C
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Procedures
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Starting on Day 21, should be collected at least weekly until counts have recovered. After counts have recovered beyond Day 21, hematology assessment should be collected only on date of bone marrow aspiration
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	GGT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LDH	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Only as needed (eg, if renal function has decreased).
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of childbearing potential
			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Urine or serum. For women of childbearing potential
			Pre-Medications
  	ondansetron/dexAMETHasone 16 mg/12 mg in NS 50 mL IVPB	Dose: 50 mL	Route: intravenous	once @ 200 mL/hr over 15 Minutes for 1 dose	Start: S					Chemotherapy
  	cytarabine PF (CYSTOSAR) 3 g/m2 in dextrose 5% 500 mL chemo IVPB	Dose: 3 g/m2	Route: intravenous	every 12 hours over 180 Minutes for 2 doses			Offset: 30 Minutes	Instructions:	For participants <60 years old: cytarabine 3.0 g/m2 IV; 
For participants >=60 years old: cytarabine 1.5 g/m2 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CYTARABINE (PF) 2 GRAM/20 ML (100 MG/ML) INJECTION SOLUTION	Medications	3 g/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	500 mL	No	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	500 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: Until discontinued	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: Until discontinued	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: Until discontinued	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN	Start: S				  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
				Day 2 - Day of Rest	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	Interval: --	Occurrences: --	Comments:	Day of Rest
				Day 3	Perform every 1 day x1			Research tolerance: -0/+0 days	Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			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
			Pre-Medications
  	ondansetron/dexAMETHasone 16 mg/12 mg in NS 50 mL IVPB	Dose: 50 mL	Route: intravenous	once @ 200 mL/hr over 15 Minutes for 1 dose	Start: S					Chemotherapy
  	cytarabine PF (CYSTOSAR) 3 g/m2 in dextrose 5% 500 mL chemo IVPB	Dose: 3 g/m2	Route: intravenous	every 12 hours over 180 Minutes for 2 doses			Offset: 30 Minutes	Instructions:	For participants <60 years old: cytarabine 3.0 g/m2 IV; 
For participants >=60 years old: cytarabine 1.5 g/m2 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CYTARABINE (PF) 2 GRAM/20 ML (100 MG/ML) INJECTION SOLUTION	Medications	3 g/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	500 mL	No	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	500 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: Until discontinued	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: Until discontinued	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: Until discontinued	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN	Start: S				  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S						Day 4 - Day of Rest	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	Interval: --	Occurrences: --	Comments:	Day of Rest
				Day 5	Perform every 1 day x1			Research tolerance: -0/+0 days	Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			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
			Pre-Medications
  	ondansetron/dexAMETHasone 16 mg/12 mg in NS 50 mL IVPB	Dose: 50 mL	Route: intravenous	once @ 200 mL/hr over 15 Minutes for 1 dose	Start: S					Chemotherapy
  	cytarabine PF (CYSTOSAR) 3 g/m2 in dextrose 5% 500 mL chemo IVPB	Dose: 3 g/m2	Route: intravenous	every 12 hours over 180 Minutes for 2 doses			Offset: 30 Minutes	Instructions:	For participants <60 years old: cytarabine 3.0 g/m2 IV; 
For participants >=60 years old: cytarabine 1.5 g/m2 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CYTARABINE (PF) 2 GRAM/20 ML (100 MG/ML) INJECTION SOLUTION	Medications	3 g/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	500 mL	No	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	500 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: Until discontinued	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: Until discontinued	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: Until discontinued	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN	Start: S				  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S						Day 6	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
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Quizartinib/placebo will be administered at 60 mg orally once daily for 14 consecutive days, starting on Day 6
			Nursing Orders
☑	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Quizartinib Placebo Dispensation from IRT.Where feasible, IRT dispensation and quizartinib/placebo administration should occur on the same day. A -3 day window between IRT dispensation and actual drug administration is permissible if logistically necessary (e.g. investigational pharmacy closures on weekends and holidays). Actual administration is to be recorded in EDC
		☑	INV-QUIZARTINIB/PLACEBO 20 MG (ACC220-168/PRO00038439/SHAH) TABLET	Dose: --	Route: oral	daily	Start: S			Instructions:	Hazardous.  Take by mouth once daily with or without food for 14 consecutive days starting from D8 during induction and from D6 during consolidation, then continuous dosing for 36 cycles, 28 days per cycle.  Take at the same time each day. Do not crush or cut tablets for oral administration.  For NG: crush and mixh with 10mL of water per tablet.		☑	INV-QUIZARTINIB/PLACEBO 30 MG (ACC220-168/PRO00038439/SHAH) TABLET	Dose: --	Route: oral	once for 1 dose	Start: S			Instructions:	Hazardous.  Take by mouth once daily with or without food for 14 consecutive days starting from D8 during induction and from D6 during consolidation, then continuous dosing for 36 cycles, 28 days per cycle.  Take at the same time each day. Do not crush or cut tablets for oral administration.  For NG: crush and mixh with 10mL of water per tablet.			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Starting on Day 21, should be collected at least weekly until counts have recovered. After counts have recovered beyond Day 21, hematology assessment should be collected only on date of bone marrow aspiration
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	GGT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LDH	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
			Procedures
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
				Day 7 - Day of Rest	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	Interval: --	Occurrences: --	Comments:	Day of Rest
				Day 8	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
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	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 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
				Day 13	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
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	IL46
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PGI-C
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Starting on Day 21, should be collected at least weekly until counts have recovered. After counts have recovered beyond Day 21, hematology assessment should be collected only on date of bone marrow aspiration
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	GGT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LDH	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
			Procedures
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
				Day 15	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:	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 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
			Procedures
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
				Day 16	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: Until discontinued	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: Until discontinued	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: Until discontinued	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN	Start: S				  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.				Day 17	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
				Day 18	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
				Day 19	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	Interval: --	Occurrences: --	Comments:	Collect Quizartinib/Placebo Returned/Assess Treatment Compliance
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Starting on Day 21, should be collected at least weekly until counts have recovered. After counts have recovered beyond Day 21, hematology assessment should be collected only on date of bone marrow aspiration
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	GGT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LDH	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Only collected for participants undergoing intensive PK in the PK-ECG Sub-study. When collected at the same schedule time as PK samples, PIA samples will be collected immediately after PK samples. Pre-dose and 4 hours post-dose.
			Procedures
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
				Day 20	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
				Day 21	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
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	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 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Physical examination should be performed on the same date as the bone marrow aspiration
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Response assessment to : Response assessment will be based on local assessments (BMA or
biopsy/CBC/physical examination to assess for signs and symptoms of extramedullary disease) using the response criteria as defined in Table 8.1. IRC will retrospectively review local assessments to determine response. If the bone marrow assessment is consistent with remission but peripheral blood counts are not recovered within 14 days of the
initial sample for response assessment, a repeat bone marrow examination is required for remission assessment at the time of count recovery.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Local and Central Bone Marrow Collection : Collect bone marrow sample upon count recovery but no later than Day 42. If counts have not recovered, a bone marrow sample must be performed by Day 42. It is not recommended to perform an aplasia assessment of response prior to Day 21. If the bone marrow assessment is consistent with remission but peripheral blood counts are not recovered within 14 days of the initial sample for response assessment, a repeat bone marrow sample is required at the time of count recovery.
			Nursing Orders
  	ONC NURSING COMMUNICATION	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.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	GGT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LDH	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
				Day 22	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:	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 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
				Day 23	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
				Day 24	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
				Day 25	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
				Day 26	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
				Day 27	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
				Day 28	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
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	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 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Physical examination should be performed on the same date as the bone marrow aspiration
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Response assessment to : Response assessment will be based on local assessments (BMA or
biopsy/CBC/physical examination to assess for signs and symptoms of extramedullary disease) using the response criteria as defined in Table 8.1. IRC will retrospectively review local assessments to determine response. If the bone marrow assessment is consistent with remission but peripheral blood counts are not recovered within 14 days of the
initial sample for response assessment, a repeat bone marrow examination is required for remission assessment at the time of count recovery.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Local and Central Bone Marrow Collection : Collect bone marrow sample upon count recovery but no later than Day 42. If counts have not recovered, a bone marrow sample must be performed by Day 42. It is not recommended to perform an aplasia assessment of response prior to Day 21. If the bone marrow assessment is consistent with remission but peripheral blood counts are not recovered within 14 days of the initial sample for response assessment, a repeat bone marrow sample is required at the time of count recovery.
			Nursing Orders
  	ONC NURSING COMMUNICATION	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.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	OP RSH PRO00038439 / AC220-168 EORTC QLQC30, PGI-S, EQ- 5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	IL46
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PGI-C
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Healthcare Resource Authorization
			Procedures
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	GGT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LDH	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
					
Cycle 4	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			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
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	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 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Physical examination should be performed on the same date as the bone marrow aspiration
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	OP RSH PRO00038439 / AC220-168 EORTC QLQC30, PGI-S, EQ- 5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	IL46
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PGI-C
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Procedures
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Starting on Day 21, should be collected at least weekly until counts have recovered. After counts have recovered beyond Day 21, hematology assessment should be collected only on date of bone marrow aspiration
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	GGT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LDH	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Only as needed (eg, if renal function has decreased).
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of childbearing potential
			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Urine or serum. For women of childbearing potential
			Pre-Medications
  	ondansetron/dexAMETHasone 16 mg/12 mg in NS 50 mL IVPB	Dose: 50 mL	Route: intravenous	once @ 200 mL/hr over 15 Minutes for 1 dose	Start: S					Chemotherapy
  	cytarabine PF (CYSTOSAR) 3 g/m2 in dextrose 5% 500 mL chemo IVPB	Dose: 3 g/m2	Route: intravenous	every 12 hours over 180 Minutes for 2 doses			Offset: 30 Minutes	Instructions:	For participants <60 years old: cytarabine 3.0 g/m2 IV; 
For participants >=60 years old: cytarabine 1.5 g/m2 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CYTARABINE (PF) 2 GRAM/20 ML (100 MG/ML) INJECTION SOLUTION	Medications	3 g/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	500 mL	No	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	500 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: Until discontinued	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: Until discontinued	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: Until discontinued	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN	Start: S				  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
				Day 2 - Day of Rest	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	Interval: --	Occurrences: --	Comments:	Day of Rest
				Day 3	Perform every 1 day x1			Research tolerance: -0/+0 days	Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			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
			Pre-Medications
  	ondansetron/dexAMETHasone 16 mg/12 mg in NS 50 mL IVPB	Dose: 50 mL	Route: intravenous	once @ 200 mL/hr over 15 Minutes for 1 dose	Start: S					Chemotherapy
  	cytarabine PF (CYSTOSAR) 3 g/m2 in dextrose 5% 500 mL chemo IVPB	Dose: 3 g/m2	Route: intravenous	every 12 hours over 180 Minutes for 2 doses			Offset: 30 Minutes	Instructions:	For participants <60 years old: cytarabine 3.0 g/m2 IV; 
For participants >=60 years old: cytarabine 1.5 g/m2 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CYTARABINE (PF) 2 GRAM/20 ML (100 MG/ML) INJECTION SOLUTION	Medications	3 g/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	500 mL	No	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	500 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: Until discontinued	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: Until discontinued	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: Until discontinued	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN	Start: S				  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S						Day 4 - Day of Rest	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	Interval: --	Occurrences: --	Comments:	Day of Rest
				Day 5	Perform every 1 day x1			Research tolerance: -0/+0 days	Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			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
			Pre-Medications
  	ondansetron/dexAMETHasone 16 mg/12 mg in NS 50 mL IVPB	Dose: 50 mL	Route: intravenous	once @ 200 mL/hr over 15 Minutes for 1 dose	Start: S					Chemotherapy
  	cytarabine PF (CYSTOSAR) 3 g/m2 in dextrose 5% 500 mL chemo IVPB	Dose: 3 g/m2	Route: intravenous	every 12 hours over 180 Minutes for 2 doses			Offset: 30 Minutes	Instructions:	For participants <60 years old: cytarabine 3.0 g/m2 IV; 
For participants >=60 years old: cytarabine 1.5 g/m2 
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CYTARABINE (PF) 2 GRAM/20 ML (100 MG/ML) INJECTION SOLUTION	Medications	3 g/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	500 mL	No	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	500 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: Until discontinued	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: Until discontinued	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: Until discontinued	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN	Start: S				  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S						Day 6	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
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 68	Interval: --	Occurrences: --	Comments:	Quizartinib/placebo will be administered at 60 mg orally once daily for 14 consecutive days, starting on Day 6
			Nursing Orders
☑	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Quizartinib Placebo Dispensation from IRT.Where feasible, IRT dispensation and quizartinib/placebo administration should occur on the same day. A -3 day window between IRT dispensation and actual drug administration is permissible if logistically necessary (e.g. investigational pharmacy closures on weekends and holidays). Actual administration is to be recorded in EDC
		☑	INV-QUIZARTINIB/PLACEBO 20 MG (ACC220-168/PRO00038439/SHAH) TABLET	Dose: --	Route: oral	daily	Start: S			Instructions:	Hazardous.  Take by mouth once daily with or without food for 14 consecutive days starting from D8 during induction and from D6 during consolidation, then continuous dosing for 36 cycles, 28 days per cycle.  Take at the same time each day. Do not crush or cut tablets for oral administration.  For NG: crush and mixh with 10mL of water per tablet.		☑	INV-QUIZARTINIB/PLACEBO 30 MG (ACC220-168/PRO00038439/SHAH) TABLET	Dose: --	Route: oral	once for 1 dose	Start: S			Instructions:	Hazardous.  Take by mouth once daily with or without food for 14 consecutive days starting from D8 during induction and from D6 during consolidation, then continuous dosing for 36 cycles, 28 days per cycle.  Take at the same time each day. Do not crush or cut tablets for oral administration.  For NG: crush and mixh with 10mL of water per tablet.			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Starting on Day 21, should be collected at least weekly until counts have recovered. After counts have recovered beyond Day 21, hematology assessment should be collected only on date of bone marrow aspiration
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	GGT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LDH	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
			Procedures
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
				Day 7 - Day of Rest	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	Interval: --	Occurrences: --	Comments:	Day of Rest
				Day 8	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
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	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 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
				Day 13	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
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	IL46
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PGI-C
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Starting on Day 21, should be collected at least weekly until counts have recovered. After counts have recovered beyond Day 21, hematology assessment should be collected only on date of bone marrow aspiration
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	GGT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LDH	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
			Procedures
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
				Day 15	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:	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 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
			Procedures
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
				Day 16	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
				Day 17	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
				Day 18	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
				Day 19	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	Interval: --	Occurrences: --	Comments:	Collect Quizartinib/Placebo Returned/Assess Treatment Compliance
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Starting on Day 21, should be collected at least weekly until counts have recovered. After counts have recovered beyond Day 21, hematology assessment should be collected only on date of bone marrow aspiration
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	GGT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LDH	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Only collected for participants undergoing intensive PK in the PK-ECG Sub-study. When collected at the same schedule time as PK samples, PIA samples will be collected immediately after PK samples. Pre-dose and 4 hours post-dose.
			Procedures
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
				Day 20	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
				Day 21	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
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	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 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Physical examination should be performed on the same date as the bone marrow aspiration
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Response assessment to : Response assessment will be based on local assessments (BMA or
biopsy/CBC/physical examination to assess for signs and symptoms of extramedullary disease) using the response criteria as defined in Table 8.1. IRC will retrospectively review local assessments to determine response. If the bone marrow assessment is consistent with remission but peripheral blood counts are not recovered within 14 days of the
initial sample for response assessment, a repeat bone marrow examination is required for remission assessment at the time of count recovery.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Local and Central Bone Marrow Collection : Collect bone marrow sample upon count recovery but no later than Day 42. If counts have not recovered, a bone marrow sample must be performed by Day 42. It is not recommended to perform an aplasia assessment of response prior to Day 21. If the bone marrow assessment is consistent with remission but peripheral blood counts are not recovered within 14 days of the initial sample for response assessment, a repeat bone marrow sample is required at the time of count recovery.
			Nursing Orders
  	ONC NURSING COMMUNICATION	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.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	GGT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LDH	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
				Day 22	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:	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 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
				Day 23	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
				Day 24	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
				Day 25	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
				Day 26	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
				Day 27	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
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
				Day 28	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
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	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 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Physical examination should be performed on the same date as the bone marrow aspiration
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Response assessment to : Response assessment will be based on local assessments (BMA or
biopsy/CBC/physical examination to assess for signs and symptoms of extramedullary disease) using the response criteria as defined in Table 8.1. IRC will retrospectively review local assessments to determine response. If the bone marrow assessment is consistent with remission but peripheral blood counts are not recovered within 14 days of the
initial sample for response assessment, a repeat bone marrow examination is required for remission assessment at the time of count recovery.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Local and Central Bone Marrow Collection : Collect bone marrow sample upon count recovery but no later than Day 42. If counts have not recovered, a bone marrow sample must be performed by Day 42. It is not recommended to perform an aplasia assessment of response prior to Day 21. If the bone marrow assessment is consistent with remission but peripheral blood counts are not recovered within 14 days of the initial sample for response assessment, a repeat bone marrow sample is required at the time of count recovery.
			Nursing Orders
  	ONC NURSING COMMUNICATION	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.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	OP RSH PRO00038439 / AC220-168 EORTC QLQC30, PGI-S, EQ- 5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	IL46
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PGI-C
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Healthcare Resource Authorization
			Procedures
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	GGT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LDH	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
			Labs
  	POTASSIUM LEVEL	Interval: --	Occurrences: --	Comments:	Monitoring for the presence of hypokalemia should be performed at least 3 times per week on the days of cytarabine administration. Potassium levels will then be checked at routine site visits  where chemistries are being collected. If hypokalemia is then identified, potassium should be monitored at least 3 times a week until the levels normalize.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect BMA on Day 21 to 35. If the Day 21-35 bone marrow does not provide an accurate assessment of response, the bone marrow procedure should be repeated upon count recovery on or up to Day 60.
					
EOT	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -3/+3 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
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	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 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Physical examination should be performed on the same date as the bone marrow aspiration
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Local and Central Bone Marrow Collection : Collect bone marrow sample upon count recovery but no later than Day 42. If counts have not recovered, a bone marrow sample must be performed by Day 42. It is not recommended to perform an aplasia assessment of response prior to Day 21. If the bone marrow assessment is consistent with remission but peripheral blood counts are not recovered within 14 days of the initial sample for response assessment, a repeat bone marrow sample is required at the time of count recovery.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Exploratory Biomarker Assessment:  Collect and analyze bone marrow aspirate sample.
			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.
			Nursing Orders
  	ONC NURSING COMMUNICATION	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.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	OP RSH PRO00038439 / AC220-168 EORTC QLQC30, PGI-S, EQ- 5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PGI-C
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Healthcare Resource Authorization
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Collect Quizartinib/Placebo Returned/Assess Treatment Compliance
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Procedures
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be triplicate and must be obtained as close as possible but no more than 2 minutes apart.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Starting on Day 21, should be collected at least weekly until counts have recovered. After counts have recovered beyond Day 21, hematology assessment should be collected only on date of bone marrow aspiration
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	GGT	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LDH	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	LIPASE LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
		  	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	After Day 21, chemistry should be collected if clinically indicated.  CMP, bilirubin direct, GGT, LDH, lipase, magnesium, phosphorus, uric acid
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Only as needed (eg, if renal function has decreased).
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of childbearing potential
			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Urine or serum. For women of childbearing potential