Protocol Index	

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RESEARCH CTL H-35253 ROUCE MABEL	

Types:      Research Oncology Treatment, ONCOLOGY SUPPORTIVE CARE
Synonyms:  RESEARCH, CTL, H35253, H-35253, ROUCE MABEL, ROUCE, MABEL

Cycle 1	Repeat 1 time	Cycle length: 5 days	Chemo: Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 10	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	OK TO USE	Interval: --	Occurrences: --		  	ACCESS PORTACATH	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	EPSTEIN BARR VIRUS (EBV) BY PCR	Interval: --	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Research Coordinator:  Please schedule Required Studies.
			Pre-Hydration
  	sodium chloride 0.9% infusion	Dose: 750 mL/m2/hr	Route: intravenous	continuous over 1 Hours	Start: S			Instructions:	If urine specific gravity is GREATER THAN 1.010 after this, give NS bolus of 300mL/m2 over 30 min.		  	sodium chloride 0.9% infusion 300 mL/m2 (Treatment Plan)	Dose: 300 mL/m2	Route: intravenous	continuous over 30 Minutes	Start: S			Instructions:	Bolus			Chemotherapy
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Hour 0 - 1: Administer cyclophosphamide
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Hour 1 - 1.5: Administer fludarabine
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Hour 1.5 - 3.5: Decrease NS to *** (375 mL/m2/hr) for 2 hours.
				Chemo: Day 2	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 10	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	OK TO USE	Interval: --	Occurrences: --		  	ACCESS PORTACATH	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Research Coordinator:  Please schedule Required Studies.
			Pre-Hydration
  	sodium chloride 0.9% infusion	Dose: 750 mL/m2/hr	Route: intravenous	continuous over 1 Hours	Start: S			Instructions:	If urine specific gravity is GREATER THAN 1.010 after this, give NS bolus of 300mL/m2 over 30 min.		  	sodium chloride 0.9% infusion 300 mL/m2 (Treatment Plan)	Dose: 300 mL/m2	Route: intravenous	continuous over 30 Minutes	Start: S			Instructions:	Bolus			Chemotherapy
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Hour 0 - 1: Administer cyclophosphamide
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Hour 1 - 1.5: Administer fludarabine
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Hour 1.5 - 3.5: Decrease NS to *** (375 mL/m2/hr) for 2 hours.
				Chemo: Day 3	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 10	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	OK TO USE	Interval: --	Occurrences: --		  	ACCESS PORTACATH	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Research Coordinator:  Please schedule Required Studies.
			Pre-Hydration
  	sodium chloride 0.9% infusion	Dose: 750 mL/m2/hr	Route: intravenous	continuous over 1 Hours	Start: S			Instructions:	If urine specific gravity is GREATER THAN 1.010 after this, give NS bolus of 300mL/m2 over 30 min.		  	sodium chloride 0.9% infusion 300 mL/m2 (Treatment Plan)	Dose: 300 mL/m2	Route: intravenous	continuous over 30 Minutes	Start: S			Instructions:	Bolus			Chemotherapy
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Hour 0 - 1: Administer cyclophosphamide
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Hour 1 - 1.5: Administer fludarabine
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Hour 1.5 - 3.5: Decrease NS to *** (375 mL/m2/hr) for 2 hours.
				T-Cell Infusion	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 4	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	(Include breath sounds) Pre-Infusion and During Infusion.  

Starting Post Infusion:  Monitor Every 30 minutes x 2, Then Every 1 hour x 3.  

(Total monitoring period Post Infusion is 4 hours).
		  	RESEARCH -  PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	Continuous Pulse Oximetry for Oxygen Saturation levels GREATER than 90% During, and at least 30 minutes Post-Infusion.
		  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --	Comments:	Start peripheral IV, if no central line. Use 3-way stopcock and tubing.
		  	RESEARCH - SUPPLIES/KIT TO BEDSIDE	Interval: --	Occurrences: --	Comments:	Must be at bedside prior to infusion: Oxygen and suction set up, normal saline flushes, red caps, and syringes with needles (1mL and 3 mL).
		  	RESEARCH - ASSESS	Interval: --	Occurrences: --	Comments:	Patient for immediate reactions: 1) Allergic reactions (anaphylaxis) 2) Decreased oxygenation (due to migration of lymphocytes to lungs).
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	EPSTEIN BARR VIRUS (EBV) BY PCR	Interval: --	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Hydration
  	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
  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	every 6 hours for 2 doses	Start: S			Instructions:	Give 2 tablets 30 minutes prior to product administration and repeat dose 4 hours post product administration		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	every 6 hours for 2 doses	Start: S			Instructions:	Give 30 minutes prior to product administration and then repeat dose 4 hours post product administration			Nursing Orders
  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	Cells to be administered by physician (generally by syringe injection with 0.9% Normal Saline flush)

Verify cell dose and patient information on Component Infusion Form. Record infusion start and stop time on form and place in patient's medical record.

Clinic nurse to remain at bedside during the entire infusion

Ensure informed consent is obtained
			Emergency Medications
  	TRANSFUSION REACTION EVALUATION	Interval: Once	Occurrences: --	Comments:	Emergency Medications: Anaphylactic precautions: Keep medications at the bedside to administer per physician's orders.
		  	diphenhydrAMINE (BENADRYL) injection 50 mg	Dose: 50 mg	Route: intravenous	once PRN	Start: S			Instructions:	Keep at the bedside to administer per physician's orders.		  	hydrocortisone sodium succinate (Solu-CORTEF) injection 250 mg	Dose: 250 mg	Route: intravenous	once PRN	Start: S			Instructions:	Keep at the bedside to administer per physician's orders.		  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	once PRN	Start: S			Instructions:	Keep at the bedside to administer per physician's orders.			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
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.