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OP RESEARCH PRO00038439 / AC220-168 PLAN F: MAINTENANCE	

Types:      Research Oncology Treatment
Synonyms:  PLAN F

Cycle 1	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			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:	Eligibility Assessments
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medical History:  For participants that undergo allogeneic HSCT
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			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 Assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	MRD Assessment
			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:	Quizartinib Placebo Dispensation from IRT
		☑	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.			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
			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.
			Nursing Orders
☑	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.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	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 4	Interval: --	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 83	Interval: --	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					  	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 8	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			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
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	IL46
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PRO-CTCAE
			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
  	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.
			Nursing Orders
☑	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.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	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 4	Interval: --	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 83	Interval: --	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					  	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 15	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			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:	Physical examination should be performed on the same date as the bone marrow aspiration
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Adverse Events
		  	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.
			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.
			Nursing Orders
☑	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.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	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 4	Interval: --	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 83	Interval: --	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					  	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 21	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			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
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Response assessment will be based on local assessments (BMA/biopsy/CBC/clinical examination). 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.
			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.
			Nursing Orders
☑	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.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	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 4	Interval: --	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 83	Interval: --	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					  	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 28	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			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
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Response assessment will be based on local assessments (BMA/biopsy/CBC/clinical examination). 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.
			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.
			Nursing Orders
☑	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.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	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 4	Interval: --	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 83	Interval: --	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					  	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.
					
Cycle 2	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			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
		  	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:	Healthcare Resource Authorization
			Nursing Orders
☑	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Quizartinib Placebo Dispensation from IRT
		☑	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.			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Collect Quizartinib/Placebo Returned/Assess Treatment Compliance
			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
  	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
			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.
			Nursing Orders
☑	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.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	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 4	Interval: --	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 83	Interval: --	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					  	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 15	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			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
		  	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.
			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.
			Nursing Orders
☑	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.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	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 4	Interval: --	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 83	Interval: --	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					  	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 21	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			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
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Response assessment will be based on local assessments (BMA/biopsy/CBC/clinical examination). 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.
			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.
			Nursing Orders
☑	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.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	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 4	Interval: --	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 83	Interval: --	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					  	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 28	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			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
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Concomitant Medications
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Response assessment will be based on local assessments (BMA/biopsy/CBC/clinical examination). 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.
			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.
			Nursing Orders
☑	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.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	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 4	Interval: --	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 83	Interval: --	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					  	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.
					
Cycle 3	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			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
			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.
			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:	OP RSH PRO00038439 / AC220-168 EORTC QLQC30, PGI-S, EQ- 5D-5L
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Healthcare Resource Authorization
			Nursing Orders
☑	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Quizartinib Placebo Dispensation from IRT
		☑	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.			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Collect Quizartinib/Placebo Returned/Assess Treatment Compliance
			Nursing Orders
☑	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.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	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 4	Interval: --	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 83	Interval: --	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					  	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.
					
Cycle 4	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			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
		  	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:	Healthcare Resource Authorization
			Nursing Orders
☑	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Quizartinib Placebo Dispensation from IRT
		☑	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.			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Collect Quizartinib/Placebo Returned/Assess Treatment Compliance
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Local and Central Bone Marrow Assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Exploratory Biomarker Assessment:  Collect and analyze bone marrow aspirate sample.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	MRD Assessment
			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
  	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
			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.
			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.
			Nursing Orders
☑	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.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	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 4	Interval: --	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 83	Interval: --	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					  	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.
					
Cycle 7	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			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
		  	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:	Healthcare Resource Authorization
			Nursing Orders
☑	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Quizartinib Placebo Dispensation from IRT
		☑	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.			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Collect Quizartinib/Placebo Returned/Assess Treatment Compliance
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Local and Central Bone Marrow Assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	MRD Assessment
			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
  	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
			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.
			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.
			Nursing Orders
☑	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.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	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 4	Interval: --	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 83	Interval: --	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					  	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.
					
Cycle 10	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			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
		  	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:	Healthcare Resource Authorization
			Nursing Orders
☑	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Quizartinib Placebo Dispensation from IRT
		☑	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.			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Collect Quizartinib/Placebo Returned/Assess Treatment Compliance
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Local and Central Bone Marrow Assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	MRD Assessment
			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
  	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
			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.
			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.
			Nursing Orders
☑	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.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	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 4	Interval: --	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 83	Interval: --	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					  	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.
					
Cycle 13	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			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
		  	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:	Healthcare Resource Authorization
			Nursing Orders
☑	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Quizartinib Placebo Dispensation from IRT
		☑	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.			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Collect Quizartinib/Placebo Returned/Assess Treatment Compliance
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Local and Central Bone Marrow Assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	MRD Assessment
			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
  	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
			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.
			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.
			Nursing Orders
☑	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.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	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 4	Interval: --	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 83	Interval: --	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					  	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.
					
Cycle 19	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			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
		  	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:	Healthcare Resource Authorization
			Nursing Orders
☑	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Quizartinib Placebo Dispensation from IRT
		☑	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.			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Collect Quizartinib/Placebo Returned/Assess Treatment Compliance
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Local and Central Bone Marrow Assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	MRD Assessment
			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
  	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
			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.
			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.
			Nursing Orders
☑	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.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	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 4	Interval: --	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 83	Interval: --	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					  	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.
					
Cycle 25	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			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
		  	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:	Healthcare Resource Authorization
			Nursing Orders
☑	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Quizartinib Placebo Dispensation from IRT
		☑	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.			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Collect Quizartinib/Placebo Returned/Assess Treatment Compliance
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Local and Central Bone Marrow Assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	MRD Assessment
			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
  	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
			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.
			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.
			Nursing Orders
☑	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.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	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 4	Interval: --	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 83	Interval: --	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					  	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.
					
Cycle 36	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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.			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			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
		  	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:	Healthcare Resource Authorization
			Nursing Orders
☑	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Quizartinib Placebo Dispensation from IRT
		☑	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.			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Collect Quizartinib/Placebo Returned/Assess Treatment Compliance
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Local and Central Bone Marrow Assessment
			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
  	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
			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.
			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.
			Nursing Orders
☑	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.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	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 4	Interval: --	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 83	Interval: --	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					  	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.
					
EOT	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink: AC220-168_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 8	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			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
		  	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 will be based on local assessments (BMA/biopsy/CBC/clinical examination). 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.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Local and Central Bone Marrow Assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Exploratory Biomarker Assessment:  Collect and analyze bone marrow aspirate sample.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	MRD Assessment
			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:	Collect Quizartinib/Placebo Returned/Assess Treatment Compliance
			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
  	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