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OP/IP RESEARCH PRO00039386 CYTB323L12201 KAZZAZ	

Types:      Research Oncology Treatment
Synonyms:  

Cycle 1	Repeat 1 time	Cycle length: 20 days	Day -5	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
☐	ONC NURSING COMMUNICATION 2	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:
		☐	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for ***STUDY DRUG*** Treatment : : Refer to Section XXX (***TITLE***) Management of AEs Associated with ***STUDY DRUG***
Protocol Access Hyperlink:
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	FERRITIN LEVEL	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	BILIRUBIN, TOTAL AND DIRECT	Interval: --	Occurrences: --	Comments:	Please calculate indirect bilirubin from total and direct bilirubin results.
		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	TRIGLYCERIDES	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	EXTENDED MYOSITIS PANEL	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For females with childbearing potentials
		  	COVID-19, INFLUENZA A&B, AND RSV QUALITATIVE RT-PCR	Interval: --	Occurrences: --		  	TROPONIN T	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	NT-PROBNP	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY IGM	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --		  	HEPATITIS C VIRUS (HCV) ANTIBODY WITH REFLEX TO PCR	Interval: --	Occurrences: --		  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --		  	QUANTIFERON-TB GOLD PLUS, 4 TUBE	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Rapcabtagene Autoleucel pre lymphodepletion criteria/checklist to be completed and sent to sponsor
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Physical Exam: To be done by hematology and Principal Investigator
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Prior to lymphodepletion, complete the pre-treatment checklist.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, blood pressure, heart rate, pulse oximetry, respiratory rate. 
Subjects will be rested for at least 5 minutes. Prior to lymphodepletion, complete the pre-treatment checklist.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Confirm that rapcabtagene autoleucel final product is received at site.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Assess concomitant medication and advserse events
			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
  	LORAZepam (ATIVAN) tablet 0.5 mg	Dose: 0.5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 min before infusions		  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 min before infusions		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 min before infusions			Chemotherapy
  	INV-cycloPHOSphamide (CYTB323L12201/Pro00039386/Kazzaz) 250 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 250 mg/m2	Route: intravenous	once over 2 Hours for 1 dose			Offset: 1.5 Hours	Instructions:	Infuse intravenously over 2 hours. Stable 24 hours at room temp or 6 days refrigerated. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-CYCLOPHOSPHAMIDE 1 GRAM/50 ML INTRAVENOUS POWDER FOR SOLN (CYTB323L12201/PRO00039386/KAZZAZ)	Medications	250 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes			  	INV-fludarabine (CYTB323L12201/Pro00039386/Kazzaz) 25 mg/m2 in sodium chloride 0.9% 100 mL chemo IVPB	Dose: 25 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours	Instructions:	Infuse IV over 30 minutes.  Stable for 8 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-FLUDARABINE 50 MG/2 ML INTRAVENOUS SOLN (CYTB323L12201/PRO00039386/KAZZAZ)	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: --	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					Post Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	PK of Fludarabine
			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 -4,-3	Perform every 1 day x2			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
☐	ONC NURSING COMMUNICATION 2	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:
		☐	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for ***STUDY DRUG*** Treatment : : Refer to Section XXX (***TITLE***) Management of AEs Associated with ***STUDY DRUG***
Protocol Access Hyperlink:
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	PK of Fludarabine
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Physical Exam: To be done by hematology and Principal Investigator
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Prior to lymphodepletion, complete the pre-treatment checklist.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, blood pressure, heart rate, pulse oximetry, respiratory rate. 
Subjects will be rested for at least 5 minutes. Prior to lymphodepletion, complete the pre-treatment checklist.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Confirm that rapcabtagene autoleucel final product is received at site.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Assess concomitant medication and advserse events
			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
  	LORAZepam (ATIVAN) tablet 0.5 mg	Dose: 0.5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 min before infusions		  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 min before infusions			Chemotherapy
  	INV-cycloPHOSphamide (CYTB323L12201/Pro00039386/Kazzaz) 250 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 250 mg/m2	Route: intravenous	once over 2 Hours for 1 dose			Offset: 1.5 Hours	Instructions:	Infuse intravenously over 2 hours. Stable 24 hours at room temp or 6 days refrigerated. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-CYCLOPHOSPHAMIDE 1 GRAM/50 ML INTRAVENOUS POWDER FOR SOLN (CYTB323L12201/PRO00039386/KAZZAZ)	Medications	250 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes			  	INV-fludarabine (CYTB323L12201/Pro00039386/Kazzaz) 25 mg/m2 in sodium chloride 0.9% 100 mL chemo IVPB	Dose: 25 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3 Hours	Instructions:	Infuse IV over 30 minutes.  Stable for 8 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-FLUDARABINE 50 MG/2 ML INTRAVENOUS SOLN (CYTB323L12201/PRO00039386/KAZZAZ)	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: --	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 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
☐	ONC NURSING COMMUNICATION 2	Interval: Once	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:
		☐	ONC NURSING COMMUNICATION 5	Interval: Once	Occurrences: --	Comments:	Dose Modifications and Management for ***STUDY DRUG*** Treatment : : Refer to Section XXX (***TITLE***) Management of AEs Associated with ***STUDY DRUG***
Protocol Access Hyperlink:
			Pre Infusion Lab
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: Once	Occurrences: --		  	FERRITIN LEVEL	Interval: Once	Occurrences: --		  	GGT	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	TOTAL BILIRUBIN	Interval: Once	Occurrences: --	Comments:	Calculate indirect bilirubin from total and direct bilirubin results
		  	BILIRUBIN DIRECT	Interval: Once	Occurrences: --	Comments:	Calculate indirect bilirubin from total and direct bilirubin results
		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --		  	TRIGLYCERIDES	Interval: Once	Occurrences: --		  	URIC ACID LEVEL	Interval: Once	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: Once	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: Once	Occurrences: --		  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: Once	Occurrences: --		  	HEPATITIS B SURFACE ANTIGEN	Interval: Once	Occurrences: --		  	HEPATITIS B SURFACE ANTIBODY	Interval: Once	Occurrences: --		  	HEPATITIS B CORE ANTIBODY IGM	Interval: Once	Occurrences: --		  	HEPATITIS C VIRUS (HCV) ANTIBODY WITH REFLEX TO PCR	Interval: Once	Occurrences: --		  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: Once	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Labs of Special Interest for CRS as clinicailly indicated
CRP, FERRITIN, FIBRINOGEN, LDH, PLATELETS, aPTT, INR, D-DIMER
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Labs of Special Interest For IEC-HS as clinically indicated
FERRITIN, HEPAIC TRANSAMINASES, BILIRUBIN:DIRECT AND TOTAL, LDH, FIBRINOGEN, aPTT, INR, D-DIMER, PLATELTES, NEUTROPHILS, Hgb, TRIGLYCERIDES
			Nursing Orders
  	ECG 12-LEAD	Interval: Once	Occurrences: --	Comments:	To be done PRE infusion
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: Until discontinued	Occurrences: --	Comments:	Complete rapcabtagene autoleucel pre-treatment criteria/checklist and sent to sponsor.
		  	ONC NURSING COMMUNICATION 8	Interval: Once	Occurrences: --	Comments:	Physical Exam: To be done by hematology and Principal Investigator
		  	MEASURE WEIGHT	Interval: Once	Occurrences: --	Comments:	ONLY at pre-infusion
		  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --	Comments:	Temperature, blood pressure, heart rate, pulse oximetry, respiratory rate. 
To be done at
1. pre-infusion; 
2. immediately after start of infusion; 
3. immediately after completion of infusion
		  	ONC NURSING COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Assess concomitant medication and advserse events
		  	ONC NURSING COMMUNICATION 12	Interval: Once	Occurrences: --	Comments:	Must have results of CBC and CMP BEFORE PROCEEDING WITH INFUSION
		  	ONC NURSING COMMUNICATION 14	Interval: Once	Occurrences: --	Comments:	If tocilizumab is warranted, it will be ordered through IDS via a paper order. Dose is 8 mg/kg and if no clinical improvement after the first dose, the dose may be repeated every 8 hours as needed. Limit to a maximum of 3 doses in a 24 hour period; maximum total of 4 doses.
			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
  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before infusion			CAR-T Infusion
  	INV-Rapcabtagene autoleucel (CYTB323L12201/Pro00039386/Kazzaz) 12.5 Million Cells	Dose: 12.5 Million Cells	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Each bag will have 10-30mL in it.  Administer IV infusion via gravity.  Repeat until all bags supplied by the Sponsor for this dose have been administered. Flush entire line with NS after infusion. An IN-LINE LEUKOCYTE FILTER MUST NOT BE USED. A central venous access device such as a peripherally inserted central catheter, implant port, or Hickman line, are highly preferred, especially in the setting of poor peripheral venous access. If peripheral venous access is used for infusion, a large bore needle must be utilized.  
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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					Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --	Comments:	Temperature, blood pressure, heart rate, pulse oximetry, respiratory rate. 
To be done post-infusion: every 15 minutes for the first hour then every hour for the next 2 hours.
				Days 2,4	Perform every 2 days x2			Research tolerance: -0/+0 days	Nursing Orders
☐	ONC NURSING COMMUNICATION 2	Interval: Once	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:
		☐	ONC NURSING COMMUNICATION 5	Interval: Once	Occurrences: --	Comments:	Dose Modifications and Management for ***STUDY DRUG*** Treatment : : Refer to Section XXX (***TITLE***) Management of AEs Associated with ***STUDY DRUG***
Protocol Access Hyperlink:
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: Once	Occurrences: --		  	FERRITIN LEVEL	Interval: Once	Occurrences: --		  	GGT	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	TOTAL BILIRUBIN	Interval: Once	Occurrences: --	Comments:	Calculate indirect bilirubin from total and direct bilirubin results
		  	BILIRUBIN DIRECT	Interval: Once	Occurrences: --	Comments:	Calculate indirect bilirubin from total and direct bilirubin results
		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --		  	TRIGLYCERIDES	Interval: Once	Occurrences: --		  	URIC ACID LEVEL	Interval: Once	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: Once	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: Once	Occurrences: --		  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: Once	Occurrences: --		  	HEPATITIS B SURFACE ANTIGEN	Interval: Once	Occurrences: --		  	HEPATITIS B SURFACE ANTIBODY	Interval: Once	Occurrences: --		  	HEPATITIS B CORE ANTIBODY IGM	Interval: Once	Occurrences: --		  	HEPATITIS C VIRUS (HCV) ANTIBODY WITH REFLEX TO PCR	Interval: Once	Occurrences: --		  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: Once	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Labs of Special Interest for CRS as clinicailly indicated
CRP, FERRITIN, FIBRINOGEN, LDH, PLATELETS, aPTT, INR, D-DIMER
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Labs of Special Interest For IEC-HS as clinically indicated
FERRITIN, HEPAIC TRANSAMINASES, BILIRUBIN:DIRECT AND TOTAL, LDH, FIBRINOGEN, aPTT, INR, D-DIMER, PLATELTES, NEUTROPHILS, Hgb, TRIGLYCERIDES
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: Once	Occurrences: --	Comments:	Physical Exam: To be done by hematology and Principal Investigator
		  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --	Comments:	Temperature, blood pressure, heart rate, pulse oximetry, respiratory rate. 
To be done at
1. pre-infusion; 
2. immediately after start of infusion; 
3. immediately after completion of infusion
		  	ONC NURSING COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Assess concomitant medication and advserse events
		  	ONC NURSING COMMUNICATION 15	Interval: Once	Occurrences: --	Comments:	ICANS scoring as needed
				Days 7,11	Perform every 4 days x2			Research tolerance: -0/+0 days	Nursing Orders
☐	ONC NURSING COMMUNICATION 2	Interval: Once	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:
		☐	ONC NURSING COMMUNICATION 5	Interval: Once	Occurrences: --	Comments:	Dose Modifications and Management for ***STUDY DRUG*** Treatment : : Refer to Section XXX (***TITLE***) Management of AEs Associated with ***STUDY DRUG***
Protocol Access Hyperlink:
			Nursing Orders
  	ECG 12-LEAD	Interval: Once	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: Once	Occurrences: --		  	FERRITIN LEVEL	Interval: Once	Occurrences: --		  	GGT	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	TOTAL BILIRUBIN	Interval: Once	Occurrences: --	Comments:	Calculate indirect bilirubin from total and direct bilirubin results
		  	BILIRUBIN DIRECT	Interval: Once	Occurrences: --	Comments:	Calculate indirect bilirubin from total and direct bilirubin results
		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --		  	TRIGLYCERIDES	Interval: Once	Occurrences: --		  	URIC ACID LEVEL	Interval: Once	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: Once	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: Once	Occurrences: --		  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: Once	Occurrences: --		  	HEPATITIS B SURFACE ANTIGEN	Interval: Once	Occurrences: --		  	HEPATITIS B SURFACE ANTIBODY	Interval: Once	Occurrences: --		  	HEPATITIS B CORE ANTIBODY IGM	Interval: Once	Occurrences: --		  	HEPATITIS C VIRUS (HCV) ANTIBODY WITH REFLEX TO PCR	Interval: Once	Occurrences: --		  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: Once	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Labs of Special Interest for CRS as clinicailly indicated
CRP, FERRITIN, FIBRINOGEN, LDH, PLATELETS, aPTT, INR, D-DIMER
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Labs of Special Interest For IEC-HS as clinically indicated
FERRITIN, HEPAIC TRANSAMINASES, BILIRUBIN:DIRECT AND TOTAL, LDH, FIBRINOGEN, aPTT, INR, D-DIMER, PLATELTES, NEUTROPHILS, Hgb, TRIGLYCERIDES
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: Once	Occurrences: --	Comments:	Physical Exam: To be done by hematology and Principal Investigator
		  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --	Comments:	Temperature, blood pressure, heart rate, pulse oximetry, respiratory rate. 
To be done at
1. pre-infusion; 
2. immediately after start of infusion; 
3. immediately after completion of infusion
		  	ONC NURSING COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Assess concomitant medication and advserse events
		  	ONC NURSING COMMUNICATION 15	Interval: Once	Occurrences: --	Comments:	ICANS scoring as needed
				Day 14	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
☐	ONC NURSING COMMUNICATION 2	Interval: Once	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:
		☐	ONC NURSING COMMUNICATION 5	Interval: Once	Occurrences: --	Comments:	Dose Modifications and Management for ***STUDY DRUG*** Treatment : : Refer to Section XXX (***TITLE***) Management of AEs Associated with ***STUDY DRUG***
Protocol Access Hyperlink:
			Nursing Orders
  	ECG 12-LEAD	Interval: Once	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: Once	Occurrences: --		  	FERRITIN LEVEL	Interval: Once	Occurrences: --		  	GGT	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	TOTAL BILIRUBIN	Interval: Once	Occurrences: --	Comments:	Calculate indirect bilirubin from total and direct bilirubin results
		  	BILIRUBIN DIRECT	Interval: Once	Occurrences: --	Comments:	Calculate indirect bilirubin from total and direct bilirubin results
		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --		  	TRIGLYCERIDES	Interval: Once	Occurrences: --		  	URIC ACID LEVEL	Interval: Once	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: Once	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: Once	Occurrences: --		  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: Once	Occurrences: --		  	HEPATITIS B SURFACE ANTIGEN	Interval: Once	Occurrences: --		  	HEPATITIS B SURFACE ANTIBODY	Interval: Once	Occurrences: --		  	HEPATITIS B CORE ANTIBODY IGM	Interval: Once	Occurrences: --		  	HEPATITIS C VIRUS (HCV) ANTIBODY WITH REFLEX TO PCR	Interval: Once	Occurrences: --		  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: Once	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Labs of Special Interest for CRS as clinicailly indicated
CRP, FERRITIN, FIBRINOGEN, LDH, PLATELETS, aPTT, INR, D-DIMER
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Labs of Special Interest For IEC-HS as clinically indicated
FERRITIN, HEPAIC TRANSAMINASES, BILIRUBIN:DIRECT AND TOTAL, LDH, FIBRINOGEN, aPTT, INR, D-DIMER, PLATELTES, NEUTROPHILS, Hgb, TRIGLYCERIDES
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: Once	Occurrences: --	Comments:	Physical Exam: To be done by hematology and Principal Investigator
		  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --	Comments:	Temperature, blood pressure, heart rate, pulse oximetry, respiratory rate. 
To be done at
1. pre-infusion; 
2. immediately after start of infusion; 
3. immediately after completion of infusion
		  	ONC NURSING COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Assess concomitant medication and advserse events
		  	ONC NURSING COMMUNICATION 15	Interval: Once	Occurrences: --	Comments:	ICANS scoring as needed