If this file opens in Compatibility Mode using Microsoft Word, convert to the latest document format to avoid potential formatting issues.	

IP/OP RESEARCH PRO00035985 EA9181 NCT04530565 ARM C SHAH	

Types:      Research Oncology Treatment
Synonyms:  

Take Home Medications	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Take-Home Medications
  	sulfamethoxazole-trimethoprim (BACTRIM DS) 800-160 mg per tablet	Dose: 1 tablet	Route: oral	Every Mon, Wed, Fri	Dispense: 12 tablet	Refills: 3	Start: S				  	dasatinib (SPRYCEL) 70 mg chemo tablet	Dose: 70 mg	Route: oral	daily	Dispense: 30 tablet	Refills: 3	Start: S			Instructions:	Take with or without food; do not crush or cut; swallow whole tablet		  	PONATinib 30 mg tablet	Dose: 30 mg	Route: oral	daily	Dispense: 30 tablet	Refills: 3	Start: S			Instructions:	Take with or without food; do not crush or cut; swallow whole tablet					
Cycle 1	Repeat 1 time	Cycle length: 42 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 27	Interval: Until discontinued	Occurrences: --	Comments:	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:    EA9181-Shah
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: Until discontinued	Occurrences: --	Comments:	Dose Modifications and Management for BLINATUMOMAB Treatment:  Refer to Section 5.7.1 Protocol Access Hyperlink:   EA9181-Shah
			Provider Communication
  	ONC PROVIDER COMMUNICATION 14	Interval: Until discontinued	Occurrences: --	Comments:	For a patient who responded well to Arm A therapy and starts Blinatumomab with minimal disease burden (defined as less than 5% of blasts in the BM), the full dose of 28mcg/day is allowed to be administered earlier and even from the first day of the cycle, by investigator discretion
		  	ONC PROVIDER COMMUNICATION 15	Interval: Until discontinued	Occurrences: --	Comments:	It is recommended that patients be hospitalized for 3 days in cycle 1 and 2 days in cycle 2 for patients who responded well to Arm A (i.e., in CR). Patients not in CR after Arm A are recommended to be hospitalized for 9 days in cycle 1 and 2 days in cycle 2.
		  	ONC PROVIDER COMMUNICATION 16	Interval: Until discontinued	Occurrences: --	Comments:	Every interruption longer than one hour should be documented. If the interruption is longer than four hours, re-start of the infusion should be performed in the hospital, under supervision of the investigator. The patient should be observed overnight for possible side effects after the re-start in the hospital and can be dismissed the following day if no difficulties arise. The re-administration of the dexamethasone premedication is required. If possible, the infusion time before and after a break should sum up to 28 days treatment per cycle.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 5	Interval: Once	Occurrences: --	Comments:	Use baseline weight to calculate dose. Adjust dose for weight gains/losses of greater than or equal to 10%.
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Writing Test
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	URIC ACID LEVEL	Interval: Once	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --		  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		  	BILIRUBIN DIRECT	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: Once	Occurrences: --		  	FIBRINOGEN	Interval: Once	Occurrences: --		  	D-DIMER	Interval: Once	Occurrences: --			Nursing Orders
  	ONC DO NOT FLUSH INFUSION LINE	Interval: Until discontinued	Occurrences: --	Comments:	DO NOT FLUSH INFUSION LINE, particularly when changing infusion bags or at completion of infusion; may result in overdose and complications.
			Nursing Orders
  	ONC NURSING COMMUNICATION 108	Interval: Until discontinued	Occurrences: --	Comments:	Check for blood return prior to start of Blinatumomab infusion.  Do not check for blood return during infusion.
			Pre-Medications
  	dexamethasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	-         Use a central line to administer the IV solution
-         Do not flush the blinatumomab IV line, especially when changing infusion bags as it will create an IV bolus to be administered to the patient
-         Before flushing the catheter system, residual amounts of blinatumomab must be aspirated from the catheter system to avoid bolus administration
			Chemotherapy
  	INV-Blinatumomab (EA9181/Pro00035985/Shah) 10.375 mcg, INV-stabilizer for blinatumomab 5.5 mL in sodium chloride (NON-PVC) 0.9 % 276.33 mL IVPB	Dose: 9 mcg/day	Route: intravenous	continuous			Offset: 30 Minutes	Instructions:	Infuse at 9mcg/day (5mcg/m2/day if <45kg, max of 9mcg/day) for 7 days and then on day 8 increase to 28mcg/day (15mcg/m2/day if <45kg, max 28mcg/day). DO NOT FLUSH. Bag contains overfill. Infuse at 10mL/hour x 24 hours through a 0.2-micron inline filter. Stable 6 days refrigerated followed by a max of 2 days (48 hours) at room temp.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-BLINATUMOMAB 38.5 MCG INTRAVENOUS SOLN (EA9181/PRO00035985/SHAH)	Medications	0.83 mL	Concentration Dosed Ingredient	Yes	INV-IV SOLUTION STABILIZER FOR BLINATUMOMAB IV SOLN (EA9181/PRO00035985/SHAH)	Medications	5.5 mL	Yes	Yes	SODIUM CHLORIDE 0.9 % IV SOLP (EXCEL;NON-PVC)	Base	270 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: Until discontinued	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: Until discontinued	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: Until discontinued	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN	Start: S				  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S						Days 2,3,4,5,6,7	Perform every 1 day x6			Research tolerance: -0/+0 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 5	Interval: Once	Occurrences: --	Comments:	Use baseline weight to calculate dose. Adjust dose for weight gains/losses of greater than or equal to 10%.
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Writing Test
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	URIC ACID LEVEL	Interval: Once	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --		  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		  	BILIRUBIN DIRECT	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: Once	Occurrences: --		  	FIBRINOGEN	Interval: Once	Occurrences: --		  	D-DIMER	Interval: Once	Occurrences: --			Nursing Orders
  	ONC DO NOT FLUSH INFUSION LINE	Interval: Until discontinued	Occurrences: --	Comments:	DO NOT FLUSH INFUSION LINE, particularly when changing infusion bags or at completion of infusion; may result in overdose and complications.
			Nursing Orders
  	ONC NURSING COMMUNICATION 108	Interval: Until discontinued	Occurrences: --	Comments:	Check for blood return prior to start of Blinatumomab infusion.  Do not check for blood return during infusion.
			Chemotherapy
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	-         Use a central line to administer the IV solution
-         Do not flush the blinatumomab IV line, especially when changing infusion bags as it will create an IV bolus to be administered to the patient
-         Before flushing the catheter system, residual amounts of blinatumomab must be aspirated from the catheter system to avoid bolus administration
			Chemotherapy
  	INV-Blinatumomab (EA9181/Pro00035985/Shah) 10.375 mcg, INV-stabilizer for blinatumomab 5.5 mL in sodium chloride (NON-PVC) 0.9 % 276.33 mL IVPB	Dose: 9 mcg/day	Route: intravenous	continuous			Offset: 30 Minutes	Instructions:	Infuse at 9mcg/day (5mcg/m2/day if <45kg, max of 9mcg/day) for 7 days and then on day 8 increase to 28mcg/day (15mcg/m2/day if <45kg, max 28mcg/day). DO NOT FLUSH. Bag contains overfill. Infuse at 10mL/hour x 24 hours through a 0.2-micron inline filter. Stable 6 days refrigerated followed by a max of 2 days (48 hours) at room temp.
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-BLINATUMOMAB 38.5 MCG INTRAVENOUS SOLN (EA9181/PRO00035985/SHAH)	Medications	0.83 mL	Concentration Dosed Ingredient	Yes	INV-IV SOLUTION STABILIZER FOR BLINATUMOMAB IV SOLN (EA9181/PRO00035985/SHAH)	Medications	5.5 mL	Yes	Yes	SODIUM CHLORIDE 0.9 % IV SOLP (EXCEL;NON-PVC)	Base	270 mL	Yes	Yes					Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 5	Interval: Once	Occurrences: --	Comments:	Use baseline weight to calculate dose. Adjust dose for weight gains/losses of greater than or equal to 10%.
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Writing Test
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	URIC ACID LEVEL	Interval: Once	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --		  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		  	BILIRUBIN DIRECT	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: Once	Occurrences: --		  	FIBRINOGEN	Interval: Once	Occurrences: --		  	D-DIMER	Interval: Once	Occurrences: --			Nursing Orders
  	ONC DO NOT FLUSH INFUSION LINE	Interval: Until discontinued	Occurrences: --	Comments:	DO NOT FLUSH INFUSION LINE, particularly when changing infusion bags or at completion of infusion; may result in overdose and complications.
			Nursing Orders
  	ONC NURSING COMMUNICATION 108	Interval: Until discontinued	Occurrences: --	Comments:	Check for blood return prior to start of Blinatumomab infusion.  Do not check for blood return during infusion.
			Pre-Medications
  	dexamethasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	-         Use a central line to administer the IV solution
-         Do not flush the blinatumomab IV line, especially when changing infusion bags as it will create an IV bolus to be administered to the patient
-         Before flushing the catheter system, residual amounts of blinatumomab must be aspirated from the catheter system to avoid bolus administration
			Chemotherapy
  	INV-Blinatumomab (EA9181/Pro00035985/Shah) 32.5 mcg, INV-stabilizer for blinatumomab 5.5 mL in sodium chloride 0.9% 278.1 mL IVPB	Dose: 28 mcg/day	Route: intravenous	continuous			Offset: 30 Minutes	Instructions:	Infuse using a 0.2 micron inline filter at 28mcg/day (15mcg/m2/day if LESS than 45kg, max 28mcg/day).  Storage in a refrigerator for 6 days followed by a maximum of 2 days (48 hours) for administration. Protect from direct sunlight, but standard room lighting is ok.  
Do NOT flush.
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-BLINATUMOMAB 38.5 MCG INTRAVENOUS SOLN (EA9181/PRO00035985/SHAH)	Medications	2.6 mL	Concentration Dosed Ingredient	Yes	INV-IV SOLUTION STABILIZER FOR BLINATUMOMAB IV SOLN (EA9181/PRO00035985/SHAH)	Medications	5.5 mL	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	270 mL	Yes	Yes					Day 9	Perform every 1 day x1			Research tolerance: -0/+0 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 5	Interval: Once	Occurrences: --	Comments:	Use baseline weight to calculate dose. Adjust dose for weight gains/losses of greater than or equal to 10%.
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Writing Test
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	URIC ACID LEVEL	Interval: Once	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --		  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		  	BILIRUBIN DIRECT	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: Once	Occurrences: --		  	FIBRINOGEN	Interval: Once	Occurrences: --		  	D-DIMER	Interval: Once	Occurrences: --			Nursing Orders
  	ONC DO NOT FLUSH INFUSION LINE	Interval: Until discontinued	Occurrences: --	Comments:	DO NOT FLUSH INFUSION LINE, particularly when changing infusion bags or at completion of infusion; may result in overdose and complications.
			Nursing Orders
  	ONC NURSING COMMUNICATION 108	Interval: Until discontinued	Occurrences: --	Comments:	Check for blood return prior to start of Blinatumomab infusion.  Do not check for blood return during infusion.
			Chemotherapy
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	-         Use a central line to administer the IV solution
-         Do not flush the blinatumomab IV line, especially when changing infusion bags as it will create an IV bolus to be administered to the patient
-         Before flushing the catheter system, residual amounts of blinatumomab must be aspirated from the catheter system to avoid bolus administration
			Chemotherapy
  	INV-Blinatumomab (EA9181/Pro00035985/Shah) 32.5 mcg, INV-stabilizer for blinatumomab 5.5 mL in sodium chloride 0.9% 278.1 mL IVPB	Dose: 28 mcg/day	Route: intravenous	continuous			Offset: 30 Minutes	Instructions:	Infuse using a 0.2 micron inline filter at 28mcg/day (15mcg/m2/day if LESS than 45kg, max 28mcg/day).  Storage in a refrigerator for 6 days followed by a maximum of 2 days (48 hours) for administration. Protect from direct sunlight, but standard room lighting is ok.  
Do NOT flush.
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-BLINATUMOMAB 38.5 MCG INTRAVENOUS SOLN (EA9181/PRO00035985/SHAH)	Medications	2.6 mL	Concentration Dosed Ingredient	Yes	INV-IV SOLUTION STABILIZER FOR BLINATUMOMAB IV SOLN (EA9181/PRO00035985/SHAH)	Medications	5.5 mL	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	270 mL	Yes	Yes				Chemotherapy
  	INV-Blinatumomab (EA9181/Pro00035985/Shah) 210 mcg, INV-stabilizer for blinatumomab 2.2 mL, sodium chloride 0.9% 1 mL in sodium chloride bacteriostatic 0.9 % 110 mL IVPB - AMBULATORY PUMP	Dose: 28 mcg/day	Route: intravenous	continuous			Offset: 30 Minutes	Instructions:	**7-day bag for patient to go home with**

Infuse at 28mcg/day (15mcg/m2/day if LESS than 45kg, max 28mcg/day).  Infuse for up to 7 days .  Expires 8 days after preparation.  Protect from direct sunlight, but standard room lighting is ok.  

Caution: New Drug-Limited by Federal (USA) Law to Investigational use
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-BLINATUMOMAB 38.5 MCG INTRAVENOUS SOLN (EA9181/PRO00035985/SHAH)	Medications	16.8 mL	Concentration Dosed Ingredient	Yes	INV-IV SOLUTION STABILIZER FOR BLINATUMOMAB IV SOLN (EA9181/PRO00035985/SHAH)	Medications	2.2 mL	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Medications	1 mL	Yes	Yes	SODIUM CHLORIDE 0.9 %, BACTERIOSTATIC INJECTION SOLUTION	Base	90 mL	Yes	Yes					Days 15,22	Perform every 7 days x2			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	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:    EA9181-Shah
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for BLINATUMOMAB Treatment:  Refer to Section 5.7.1 Protocol Access Hyperlink:   EA9181-Shah
			Provider Communication
  	ONC PROVIDER COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Every interruption longer than one hour should be documented. If the interruption is longer than four hours, re-start of the infusion should be performed in the hospital, under supervision of the investigator. The patient should be observed overnight for possible side effects after the re-start in the hospital and can be dismissed the following day if no difficulties arise. The re-administration of the dexamethasone premedication is required. If possible, the infusion time before and after a break should sum up to 28 days treatment per cycle.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Use baseline weight to calculate dose. Adjust dose for weight gains/losses of greater than or equal to 10%.
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Writing Test
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	FIBRINOGEN	Interval: --	Occurrences: --		  	D-DIMER	Interval: --	Occurrences: --			Nursing Orders
  	ONC DO NOT FLUSH INFUSION LINE	Interval: --	Occurrences: --	Comments:	DO NOT FLUSH INFUSION LINE, particularly when changing infusion bags or at completion of infusion; may result in overdose and complications.
			Nursing Orders
  	ONC NURSING COMMUNICATION 108	Interval: --	Occurrences: --	Comments:	Check for blood return prior to start of Blinatumomab infusion.  Do not check for blood return during infusion.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	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.			Chemotherapy
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	-         Use a central line to administer the IV solution
-         Do not flush the blinatumomab IV line, especially when changing infusion bags as it will create an IV bolus to be administered to the patient
-         Before flushing the catheter system, residual amounts of blinatumomab must be aspirated from the catheter system to avoid bolus administration
			Chemotherapy
  	INV-Blinatumomab (EA9181/Pro00035985/Shah) 210 mcg, INV-stabilizer for blinatumomab 2.2 mL, sodium chloride 0.9% 1 mL in sodium chloride bacteriostatic 0.9 % 110 mL IVPB - AMBULATORY PUMP	Dose: 28 mcg/day	Route: intravenous	continuous			Offset: 30 Minutes	Instructions:	Infuse at 28mcg/day (15mcg/m2/day if LESS than 45kg, max 28mcg/day).  Infuse for up to 7 days .  Expires 8 days after preparation.  Protect from direct sunlight, but standard room lighting is ok.  

Caution: New Drug-Limited by Federal (USA) Law to Investigational use	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-BLINATUMOMAB 38.5 MCG INTRAVENOUS SOLN (EA9181/PRO00035985/SHAH)	Medications	16.8 mL	Concentration Dosed Ingredient	Yes	INV-IV SOLUTION STABILIZER FOR BLINATUMOMAB IV SOLN (EA9181/PRO00035985/SHAH)	Medications	2.2 mL	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Medications	1 mL	Yes	Yes	SODIUM CHLORIDE 0.9 %, BACTERIOSTATIC INJECTION SOLUTION	Base	90 mL	Yes	Yes				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.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	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
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			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				Day 29	Perform every 1 day x1			Research tolerance: -0/+0 days	Intrathecal Injections
  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	IT chemo should be administerd after last blinatumomab infusion is completed in Cycle 1
			Appointment Requests
  	IR LUMBAR PUNCTURE	Interval: --	Occurrences: --			Intrathecal Injections
  	methotrexate PF 12.5 mg in sodium chloride 0.9% 6 mL chemo PF INTRATHECAL injection	Dose: 12.5 mg	Route: intrathecal	once over 5 Minutes for 1 dose	Start: S	End: S		Instructions:	Preservative free for intrathecal use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	METHOTREXATE SODIUM (PF) 25 MG/ML INJECTION SOLUTION	Medications	12.5 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INJECTION SOLUTION	QS Base	5.5 mL	Yes	Yes						
Cycle 2	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 27	Interval: Until discontinued	Occurrences: --	Comments:	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:    EA9181-Shah
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: Until discontinued	Occurrences: --	Comments:	Dose Modifications and Management for BLINATUMOMAB Treatment:  Refer to Section 5.7.1 Protocol Access Hyperlink:   EA9181-Shah
			Provider Communication
  	ONC PROVIDER COMMUNICATION 15	Interval: Until discontinued	Occurrences: --	Comments:	It is recommended that patients be hospitalized for 3 days in cycle 1 and 2 days in cycle 2 for patients who responded well to Arm A (i.e., in CR). Patients not in CR after Arm A are recommended to be hospitalized for 9 days in cycle 1 and 2 days in cycle 2.
		  	ONC PROVIDER COMMUNICATION 16	Interval: Until discontinued	Occurrences: --	Comments:	Every interruption longer than one hour should be documented. If the interruption is longer than four hours, re-start of the infusion should be performed in the hospital, under supervision of the investigator. The patient should be observed overnight for possible side effects after the re-start in the hospital and can be dismissed the following day if no difficulties arise. The re-administration of the dexamethasone premedication is required. If possible, the infusion time before and after a break should sum up to 28 days treatment per cycle.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 5	Interval: Once	Occurrences: --	Comments:	Use baseline weight to calculate dose. Adjust dose for weight gains/losses of greater than or equal to 10%.
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Writing Test
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	URIC ACID LEVEL	Interval: Once	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --		  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		  	BILIRUBIN DIRECT	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: Once	Occurrences: --		  	FIBRINOGEN	Interval: Once	Occurrences: --		  	D-DIMER	Interval: Once	Occurrences: --			Nursing Orders
  	ONC DO NOT FLUSH INFUSION LINE	Interval: --	Occurrences: --	Comments:	DO NOT FLUSH INFUSION LINE, particularly when changing infusion bags or at completion of infusion; may result in overdose and complications.
			Nursing Orders
  	ONC NURSING COMMUNICATION 108	Interval: Until discontinued	Occurrences: --	Comments:	Check for blood return prior to start of Blinatumomab infusion.  Do not check for blood return during infusion.
			Pre-Medications
  	dexamethasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	-         Use a central line to administer the IV solution
-         Do not flush the blinatumomab IV line, especially when changing infusion bags as it will create an IV bolus to be administered to the patient
-         Before flushing the catheter system, residual amounts of blinatumomab must be aspirated from the catheter system to avoid bolus administration
			Chemotherapy
  	INV-Blinatumomab (EA9181/Pro00035985/Shah) 32.5 mcg, INV-stabilizer for blinatumomab 5.5 mL in sodium chloride 0.9% 278.1 mL IVPB	Dose: 28 mcg/day	Route: intravenous	continuous			Offset: 30 Minutes	Instructions:	Infuse using a 0.2 micron inline filter at 28mcg/day (15mcg/m2/day if LESS than 45kg, max 28mcg/day).  Storage in a refrigerator for 6 days followed by a maximum of 2 days (48 hours) for administration. Protect from direct sunlight, but standard room lighting is ok.  
Do NOT flush.
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-BLINATUMOMAB 38.5 MCG INTRAVENOUS SOLN (EA9181/PRO00035985/SHAH)	Medications	2.6 mL	Concentration Dosed Ingredient	Yes	INV-IV SOLUTION STABILIZER FOR BLINATUMOMAB IV SOLN (EA9181/PRO00035985/SHAH)	Medications	5.5 mL	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	270 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: Until discontinued	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: Until discontinued	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: Until discontinued	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN	Start: S				  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S						Day 2	Perform every 1 day x1			Research tolerance: -0/+0 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 5	Interval: Once	Occurrences: --	Comments:	Use baseline weight to calculate dose. Adjust dose for weight gains/losses of greater than or equal to 10%.
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Writing Test
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	URIC ACID LEVEL	Interval: Once	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --		  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		  	BILIRUBIN DIRECT	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: Once	Occurrences: --		  	FIBRINOGEN	Interval: Once	Occurrences: --		  	D-DIMER	Interval: Once	Occurrences: --			Nursing Orders
  	ONC DO NOT FLUSH INFUSION LINE	Interval: --	Occurrences: --	Comments:	DO NOT FLUSH INFUSION LINE, particularly when changing infusion bags or at completion of infusion; may result in overdose and complications.
			Nursing Orders
  	ONC NURSING COMMUNICATION 108	Interval: Until discontinued	Occurrences: --	Comments:	Check for blood return prior to start of Blinatumomab infusion.  Do not check for blood return during infusion.
			Chemotherapy
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	-         Use a central line to administer the IV solution
-         Do not flush the blinatumomab IV line, especially when changing infusion bags as it will create an IV bolus to be administered to the patient
-         Before flushing the catheter system, residual amounts of blinatumomab must be aspirated from the catheter system to avoid bolus administration
			Chemotherapy
  	INV-Blinatumomab (EA9181/Pro00035985/Shah) 32.5 mcg, INV-stabilizer for blinatumomab 5.5 mL in sodium chloride 0.9% 278.1 mL IVPB	Dose: 28 mcg/day	Route: intravenous	continuous			Offset: 30 Minutes	Instructions:	Infuse using a 0.2 micron inline filter at 28mcg/day (15mcg/m2/day if LESS than 45kg, max 28mcg/day).  Storage in a refrigerator for 6 days followed by a maximum of 2 days (48 hours) for administration. Protect from direct sunlight, but standard room lighting is ok.  
Do NOT flush.
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-BLINATUMOMAB 38.5 MCG INTRAVENOUS SOLN (EA9181/PRO00035985/SHAH)	Medications	2.6 mL	Concentration Dosed Ingredient	Yes	INV-IV SOLUTION STABILIZER FOR BLINATUMOMAB IV SOLN (EA9181/PRO00035985/SHAH)	Medications	5.5 mL	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	270 mL	Yes	Yes				Chemotherapy
  	INV-Blinatumomab (EA9181/Pro00035985/Shah) 210 mcg, INV-stabilizer for blinatumomab 2.2 mL, sodium chloride 0.9% 1 mL in sodium chloride bacteriostatic 0.9 % 110 mL IVPB - AMBULATORY PUMP	Dose: 28 mcg/day	Route: intravenous	continuous			Offset: 30 Minutes	Instructions:	**7-day bag for patient to go home with**

Infuse at 28mcg/day (15mcg/m2/day if LESS than 45kg, max 28mcg/day).  Infuse for up to 7 days .  Expires 8 days after preparation.  Protect from direct sunlight, but standard room lighting is ok.  

Caution: New Drug-Limited by Federal (USA) Law to Investigational use
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-BLINATUMOMAB 38.5 MCG INTRAVENOUS SOLN (EA9181/PRO00035985/SHAH)	Medications	16.8 mL	Concentration Dosed Ingredient	Yes	INV-IV SOLUTION STABILIZER FOR BLINATUMOMAB IV SOLN (EA9181/PRO00035985/SHAH)	Medications	2.2 mL	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Medications	1 mL	Yes	Yes	SODIUM CHLORIDE 0.9 %, BACTERIOSTATIC INJECTION SOLUTION	Base	90 mL	Yes	Yes					Days 8,15,22	Perform every 7 days x3			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	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:    EA9181-Shah
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for BLINATUMOMAB Treatment:  Refer to Section 5.7.1 Protocol Access Hyperlink:   EA9181-Shah
			Provider Communication
  	ONC PROVIDER COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Every interruption longer than one hour should be documented. If the interruption is longer than four hours, re-start of the infusion should be performed in the hospital, under supervision of the investigator. The patient should be observed overnight for possible side effects after the re-start in the hospital and can be dismissed the following day if no difficulties arise. The re-administration of the dexamethasone premedication is required. If possible, the infusion time before and after a break should sum up to 28 days treatment per cycle.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Use baseline weight to calculate dose. Adjust dose for weight gains/losses of greater than or equal to 10%.
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Writing Test
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	FIBRINOGEN	Interval: --	Occurrences: --		  	D-DIMER	Interval: --	Occurrences: --			Nursing Orders
  	ONC DO NOT FLUSH INFUSION LINE	Interval: --	Occurrences: --	Comments:	DO NOT FLUSH INFUSION LINE, particularly when changing infusion bags or at completion of infusion; may result in overdose and complications.
			Nursing Orders
  	ONC NURSING COMMUNICATION 108	Interval: --	Occurrences: --	Comments:	Check for blood return prior to start of Blinatumomab infusion.  Do not check for blood return during infusion.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	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.			Chemotherapy
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	-         Use a central line to administer the IV solution
-         Do not flush the blinatumomab IV line, especially when changing infusion bags as it will create an IV bolus to be administered to the patient
-         Before flushing the catheter system, residual amounts of blinatumomab must be aspirated from the catheter system to avoid bolus administration
			Chemotherapy
  	INV-Blinatumomab (EA9181/Pro00035985/Shah) 210 mcg, INV-stabilizer for blinatumomab 2.2 mL, sodium chloride 0.9% 1 mL in sodium chloride bacteriostatic 0.9 % 110 mL IVPB - AMBULATORY PUMP	Dose: 28 mcg/day	Route: intravenous	continuous			Offset: 30 Minutes	Instructions:	Infuse at 28mcg/day (15mcg/m2/day if LESS than 45kg, max 28mcg/day).  Infuse for up to 7 days .  Expires 8 days after preparation.  Protect from direct sunlight, but standard room lighting is ok.  

Caution: New Drug-Limited by Federal (USA) Law to Investigational use	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-BLINATUMOMAB 38.5 MCG INTRAVENOUS SOLN (EA9181/PRO00035985/SHAH)	Medications	16.8 mL	Concentration Dosed Ingredient	Yes	INV-IV SOLUTION STABILIZER FOR BLINATUMOMAB IV SOLN (EA9181/PRO00035985/SHAH)	Medications	2.2 mL	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Medications	1 mL	Yes	Yes	SODIUM CHLORIDE 0.9 %, BACTERIOSTATIC INJECTION SOLUTION	Base	90 mL	Yes	Yes				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.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	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
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			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				Day 28	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Physical Examination
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	AEs
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Writing Test
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Procedures
  	BIOPSY BONE MARROW	Interval: --	Occurrences: --	Comments:	Bone Marrow Aspirate, and Biopsy - Submit two (2) original karyotypes per clone, FISH results, institution's cytogenetic laboratory report, and the Leukemia Cytogenetic Form (#365R) via Medidata Rave. Cytogenetics are only required at time of initial diagnosis and are optional at all later time points. Direct questions to Sarina Sherpa at Tel: (212) 639-8835.
			Labs
  	FLOW CYTOMETRY EVALUATION	Interval: --	Occurrences: --	Comments:	Submit two (2) original karyotypes per clone, FISH results, institution's cytogenetic laboratory report, and the Leukemia Cytogenetic Form (#365R) via Medidata Rave. Cytogenetics are only required at time of initial diagnosis and are optional at all later time points. Direct questions to Sarina Sherpa at Tel: (212) 639-8835.
		  	CYTOLOGY (NON-GYNECOLOGICAL) REQUEST	Interval: --	Occurrences: --	Comments:	Cytogenetics - Submit two (2) original karyotypes per clone, FISH results, institution's cytogenetic laboratory report, and the Leukemia Cytogenetic Form (#365R) via Medidata Rave. Cytogenetics are only required at time of initial diagnosis and are optional at all later time points. Direct questions to Sarina Sherpa at Tel: (212) 639-8835.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone marrow aspirates and peripheral blood are required to be submitted for centralized Molecular BCR-ABL status testing at the designated time points as outlined in Section 10. Submit to the Fred Hutchinson Cancer Research Center. Results will be forwarded to the submitting institution within one to two (1 - 2) business days of receipt of the specimen. The laboratory will accept any amount as long as it represents the first pull). Ideally, 2-3mL of aspirate from separate aspiration site should be submitted. In cases where the bone marrow aspiration may be inadequate, peripheral blood (10mL EDTA tube) may be submitted, given that adequate circulating blasts (>10%) are present
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Peripheral blood is to be submitted for centralized Molecular BCR-ABL status testing per patient consent. Submit from patients who answer 'Yes' to 'I agree that my samples and related health information may be used for the laboratory research studies.