Protocol Index	

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OP CAGT CYCLOPHOSPHAMIDE / FLUDARABINE / TISAGENLECLEUCEL - ACUTE LYMPHOCYTIC LEUKEMIA (ALL)	

Types:      ONCOLOGY TREATMENT
Synonyms:  CAGT, CYCLOPHOSHAMIDE, CYTOXAN, MESNA, FLUDARABINE, FLUDARA, MESNEX, FLU, KYMRIAH, TISAGENLECLEUCEL, CAR T CELL, ALL, ACUTE LYMPHOCYTIC LEUKEMIA

Cycle 1	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION 64	Interval: --	Occurrences: --	Comments:	Verify Hep B panel status prior to cycle. Date *** of panel. Result positive/negative/pending/unknown:22867

The required components for the hepatitis B panel includes: Hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (anti-HBc), and hepatitis B antibody (anti-HBs).
			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.			Hydration
  	sodium chloride 0.9 % infusion	Dose: 150 mL/hr	Route: intravenous	once over 6 Hours for 1 dose				Instructions:	Start 1 hour prior to chemotherapy.			Pre-Medications
  	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose			Offset: 30 Minutes	Instructions:	Administer 30 minutes before chemotherapy.			Pre-Medications
  	LORAZepam (ATIVAN) tablet 0.5 mg	Dose: 0.5 mg	Route: oral	once for 1 dose			Offset: 30 Minutes	Instructions:	Administer 30 minutes before chemotherapy.			Chemotherapy
  	mesna (MESNEX) 250 mg/m2 in sodium chloride 0.9% 100 mL chemo IVPB	Dose: 250 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 1 Hours	Instructions:	Administer before Mesna/Cyclophosphamide infusion.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	MESNA 100 MG/ML INTRAVENOUS SOLUTION	Medications	250 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes			  	cycloPHOSphamide (CYTOXAN) 500 mg/m2, mesna (MESNEX) 500 mg/m2 in dextrose 5% 500 mL chemo IVPB	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 1.5 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CYCLOPHOSPHAMIDE 1 GRAM INTRAVENOUS POWDER FOR SOLUTION	Medications	500 mg/m2	Yes	Yes	MESNA 100 MG/ML INTRAVENOUS SOLUTION	Medications	500 mg/m2	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	500 mL	Yes	Yes			  	fludarabine (FLUDARA) 30 mg/m2 in sodium chloride 0.9% 100 mL chemo IVPB	Dose: 30 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3.5 Hours	Instructions:	Use within 8 hours of preparation.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	FLUDARABINE 50 MG/2 ML INTRAVENOUS SOLUTION	Medications	30 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	No	Yes			  	mesna (MESNEX) oral solution 500 mg/m2 (Treatment Plan)	Dose: 500 mg/m2	Route: oral	once for 1 dose			Offset: 5.5 Hours	Instructions:	Administer TWO hours AFTER Mesna/Cyclophosphamide infusion completed.		  	mesna (MESNEX) oral solution 500 mg/m2 (Treatment Plan)	Dose: 500 mg/m2	Route: oral	once for 1 dose			Offset: 9.5 Hours	Instructions:	Administer SIX hours AFTER Mesna/Cyclophosphamide infusion completed.			Supportive Care
☐	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours 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 2	Perform every 1 day x1		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.			Hydration
  	sodium chloride 0.9 % infusion	Dose: 150 mL/hr	Route: intravenous	once over 6 Hours for 1 dose				Instructions:	Start 1 hour prior to chemotherapy.			Pre-Medications
  	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose			Offset: 30 Minutes	Instructions:	Administer 30 minutes before chemotherapy.			Pre-Medications
  	LORAZepam (ATIVAN) tablet 0.5 mg	Dose: 0.5 mg	Route: oral	once for 1 dose			Offset: 30 Minutes	Instructions:	Administer 30 minutes before chemotherapy.			Chemotherapy
  	mesna (MESNEX) 250 mg/m2 in sodium chloride 0.9% 100 mL chemo IVPB	Dose: 250 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 1 Hours	Instructions:	Administer before Mesna/Cyclophosphamide infusion.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	MESNA 100 MG/ML INTRAVENOUS SOLUTION	Medications	250 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes			  	cycloPHOSphamide (CYTOXAN) 500 mg/m2, mesna (MESNEX) 500 mg/m2 in dextrose 5% 500 mL chemo IVPB	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 1.5 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CYCLOPHOSPHAMIDE 1 GRAM INTRAVENOUS POWDER FOR SOLUTION	Medications	500 mg/m2	Yes	Yes	MESNA 100 MG/ML INTRAVENOUS SOLUTION	Medications	500 mg/m2	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	500 mL	Yes	Yes			  	fludarabine (FLUDARA) 30 mg/m2 in sodium chloride 0.9% 100 mL chemo IVPB	Dose: 30 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3.5 Hours	Instructions:	Use within 8 hours of preparation.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	FLUDARABINE 50 MG/2 ML INTRAVENOUS SOLUTION	Medications	30 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	No	Yes			  	mesna (MESNEX) oral solution 500 mg/m2 (Treatment Plan)	Dose: 500 mg/m2	Route: oral	once for 1 dose			Offset: 5.5 Hours	Instructions:	Administer TWO hours AFTER Mesna/Cyclophosphamide infusion completed.		  	mesna (MESNEX) oral solution 500 mg/m2 (Treatment Plan)	Dose: 500 mg/m2	Route: oral	once for 1 dose			Offset: 9.5 Hours	Instructions:	Administer SIX hours AFTER Mesna/Cyclophosphamide infusion completed.			Supportive Care
☐	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours 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				Days 3,4	Perform every 1 day x2		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.			Pre-Medications
  	ondansetron (ZOFRAN) tablet 8 mg	Dose: 8 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	fludarabine (FLUDARA) 30 mg/m2 in sodium chloride 0.9% 100 mL chemo IVPB	Dose: 30 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	FLUDARABINE 50 MG/2 ML INTRAVENOUS SOLUTION	Medications	30 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	No	Yes				Supportive Care
☐	promethazine (PHENERGAN) injection 25 mg	Dose: 25 mg	Route: intravenous	every 4 hours 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 7	Perform every 1 day x1		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.			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Prior to infusion, verify with pharmacy that 2 doses of tocilizumab are available and set aside for this patient.
			Pre-Medications
  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Premed for CAR-T Infusion		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Premed for CAR-T Infusion			CAR-T Infusion
  	tisagenlecleucel (KYMRIAH) infusion-ALL(RESTRICTED) 1 bag(s)	Dose: 1 bag(s)	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Administer as an IV infusion at a rate of 10 mL to 20 mL per minute until infusion bag is empty; adjust this rate as appropriate for smaller children and smaller volumes. Do not use a leukocyte-depleting filter. Rinse the infusion bag with 10 mL to 30 mL of normal saline; maintain a closed tubing system to assure as many cells as possible are infused into the patient.

Ensure that cell product infusion paper order is available, properly completed, and scanned into Epic			CAR-T Infusion Additional Orders
  	ONC NURSING COMMUNICATION 31	Interval: --	Occurrences: --	Comments:	-Oxygen at bedside during CAR-T infusion and until discharged.
-Anaphylaxis precautions at bedside during CAR-T infusion and until discharged.
		  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	- Obtain baseline vital signs (T, P, R, BP, Oxygen saturation +/- breath sounds) 
- Vital signs every 15 minutes during infusion (T, P, R, BP) 
- Vital signs (T, P, R, BP, +/- breath sounds) at completion of infusion, then at 30 minutes post & 60 minutes post infusion
		  	PULSE OXIMETRY CONTINUOUS	Interval: --	Occurrences: --	Comments:	Continuous pulse oximetry monitoring during infusion and for 30 minutes post infusion
		  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	RECORD START & STOP TIMES on component infusion form AND in EPIC
		  	meperidine (DEMEROL) injection (RESTRICTED) 12.5 mg	Dose: 12.5 mg	Route: intravenous	every 15 min PRN for 3 doses					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	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