Protocol Index	

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OP RESEARCH CTL H-54434 TSCAN002 REGIMEN C LULLA	

Types:      Research Oncology Treatment
Synonyms:  

Cycle 1	Repeat 1 time	Cycle length: 178 days	Screening	Perform every 1 day x1		Nursing Orders
  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG performance assessment
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ECG 12-LEAD	Interval: --	Occurrences: --			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	TTE (ECHO) or MUGA scan
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --				Day -7 through 0	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: Daily	Occurrences: --	Comments:	On days -7 to -3: ECOG performance assessment
		  	VITAL SIGNS - T/P/R/BP	Interval: Daily	Occurrences: --	Comments:	On days -7 to -3
		  	PULSE OXIMETRY	Interval: Daily	Occurrences: --	Comments:	On days -7 to -3
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --	Comments:	On days -7.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --	Comments:	On days -7.
		  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --	Comments:	On days -7.
		  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --	Comments:	On days -7.
		  	BILIRUBIN DIRECT	Interval: Once	Occurrences: --	Comments:	On days -7.
		  	LDH	Interval: Once	Occurrences: --	Comments:	On days -7.
		  	C-REACTIVE PROTEIN	Interval: Once	Occurrences: --	Comments:	On days -7.
		  	FERRITIN LEVEL	Interval: Once	Occurrences: --	Comments:	On days -7.
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: Once	Occurrences: --	Comments:	On days -7.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Collect daily on days -7.
			Pre-Medications
  	LORAZepam (ATIVAN) tablet 0.5 mg	Dose: 0.5 mg	Route: oral	every 24 hours for 5 doses	Start: S			Instructions:	Give 30-60 minutes before chemo on days -7, -6, -5, -4, -3. 		  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	every 24 hours for 5 doses	Start: S			Instructions:	Give 30-60 minutes before chemo on days -7, -6, -5, -4, -3. 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	every 24 hours over 30 Minutes for 5 doses	Start: S			Instructions:	Give 30-60 minutes before chemo on days -7, -6, -5, -4, -3. 			Chemotherapy
  	INV-cycloPHOSphamide (H-54434/TSCAN002/Lulla) 30 mg/kg, INV-mesna (H-54434/TSCAN002/Lulla) 30 mg/kg in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	every 24 hours over 180 Minutes for 2 doses			Offset: 30 Minutes	Instructions:	On days -7, -6. 	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-CYCLOPHOSPHAMIDE 1 GRAM INTRAVENOUS POWDER FOR SOLN (H-54434/TSCAN002/LULLA)	Medications	30 mg/kg	Yes	Yes	INV-MESNA 100 MG/ML INTRAVENOUS SOLN (H-54434/TSCAN002/LULLA)	Medications	30 mg/kg	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes			  	INV-fludarabine (H-54434/TSCAN002/Lulla) 25 mg/m2 in sodium chloride 0.9% 100 mL chemo IVPB	Dose: 25 mg/m2	Route: intravenous	every 24 hours over 30 Minutes for 5 doses			Offset: 3.5 Hours	Instructions:	On days -7, -6, -5, -4, -3. 	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-FLUDARABINE 50 MG/2 ML INTRAVENOUS SOLN (H-54434/TSCAN002/LULLA)	Medications	25 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 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	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 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 9	Interval: --	Occurrences: --			Nursing Orders
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	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:	ECOG performance assessment
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Observe patient for two hours after CTL infusion (check VS every 15 minutes)
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Check VS every 15 minutes
		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	If a peripheral line is used, use at least an 18-gauge needle to start the line.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Supplies:
Start peripheral IV, if no central line. Use 3-way stopcock and tubing.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	FERRITIN LEVEL	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 1 mg/kg (Treatment Plan)	Dose: 1 mg/kg	Route: intravenous	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: oral	once for 1 dose	Start: S						Day 3	Perform every 1 day x1		Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	FERRITIN LEVEL	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Days 8,15,22	Perform every 7 days x3		Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	FERRITIN LEVEL	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Day 23	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 9	Interval: --	Occurrences: --			Nursing Orders
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	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:	ECOG performance assessment
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Observe patient for two hours after CTL infusion (check VS every 15 minutes)
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Check VS every 15 minutes
		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	If a peripheral line is used, use at least an 18-gauge needle to start the line.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Supplies:
Start peripheral IV, if no central line. Use 3-way stopcock and tubing.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	FERRITIN LEVEL	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 1 mg/kg (Treatment Plan)	Dose: 1 mg/kg	Route: intravenous	once for 1 dose	Start: S				  	acetaminophen (TYLENOL) tablet 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: oral	once for 1 dose	Start: S						Day 43	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG performance assessment
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	FERRITIN LEVEL	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Day 57	Perform every 1 day x1		Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	FERRITIN LEVEL	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Days 85,127,169	Perform every 42 days x3		Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG performance assessment
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --