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OP/IP PRO00036989 SCHEDULE A CNTY-101 PINGALI	

Types:      Research Oncology Treatment
Synonyms:  

Lymphodepletion 	Repeat 1 time	Cycle length: 12 days	Days 1,2,3	Perform every 1 day x3		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			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-Hydration
  	sodium chloride 0.9 % infusion	Dose: 1,000 mL	Route: intravenous	once @ 500 mL/hr for 1 dose				Instructions:	Start 2 hours prior to cyclophosphamide			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
  	ONC PROVIDER COMMUNICATION 6	Interval: Until discontinued	Occurrences: --	Comments:	Reduce FLUDARABINE  dose by 20% for CrCl 60-70mL/min.  Hold dose for CrCl LESS than 60mL/min.
		  	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: 60 Minutes	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) 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: 90 Minutes	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) 300 mg/m2, mesna (MESNEX) 300 mg in dextrose 5% 250 mL chemo IVPB	Dose: --	Route: intravenous	once over 1 Hours for 1 dose			Offset: 120 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CYCLOPHOSPHAMIDE 1 GRAM INTRAVENOUS POWDER FOR SOLUTION	Medications	300 mg/m2	Yes	Yes	MESNA 100 MG/ML INTRAVENOUS SOLUTION	Medications	300 mg	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	247 mL	Yes	Yes				Hydration
  	sodium chloride 0.9 % infusion	Dose: 1,000 mL	Route: intravenous	once @ 500 mL/hr for 1 dose			Offset: 180 Minutes	Instructions:	Start after cyclophosphamide infusion completed			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.
		  	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					
Cycle 1	Repeat 1 time	Cycle length: 3 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	o Admission: all subjects will require inpatient monitoring, including hospitalization for at least 72 hours after each CNTY-101 infusion.  
o Confirm subject eligibility: form to be approved by Sponsor
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: Once	Occurrences: --	Comments:	Physical Exam Neurological Exam: 
o Physical examinations must include, at a minimum, neurological, cardiovascular, pulmonary, and lymph node examinations. In addition, symptom-directed exams should be performed.  
o The neurological exam should include, at a minimum, a physical examination to assess cranial nerves, motor and sensory skills, coordination, and balance. 
		  	VITAL SIGNS - T/P/R/BP	Interval: Once	Occurrences: --	Comments:	Include temperature, weight, respiratory rate, heart rate, blood pressure, and SaO2 by pulse oximeter,. Within 20 minutes prior to CNTY-101 infusion, and after CNTY-101 infusion, 3 times per hour for first 2 hours and hourly until stable (if inpatient monitoring) or discharge (if outpatient monitoring).
		  	ONC NURSING COMMUNICATION 5	Interval: Once	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 6	Interval: Once	Occurrences: --	Comments:	Daily call from site through D8 to assess AEs and confirm IL-2 injection.
		  	ONC NURSING COMMUNICATION 8	Interval: Once	Occurrences: --	Comments:	ICE Score
The 10-point ICE score includes grading from 10 (no impairment), 7 to 9 (mild impairment), 3 to 6 (moderate impairment), 0 to 2 (severe impairment), and 0 due to subject unarousable and unable to perform ICE assessment. ICE scores should be measured as described in Lee et al. 201986 (see the Guidelines Addendum for additional details)
		  	ONC NURSING COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	AE/SAE Assessment
		  	ONC NURSING COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Concomitant Medications
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --			Labs
  	LDH	Interval: Once	Occurrences: --			Labs
  	ABSOLUTE NEUTROPHIL COUNT	Interval: Once	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: Once	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: Once	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --			Labs
  	CHOLESTEROL	Interval: Once	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --			Labs
  	CREATININE CLEARANCE, URINE, 24 HOUR	Interval: Once	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: Once	Occurrences: --			Labs
  	C-REACTIVE PROTEIN	Interval: Once	Occurrences: --		  	FERRITIN LEVEL	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Flow cytometric analysis of whole blood will be performed to enumerate B cells pre- and post-infusion. Development of B-cell aplasia, a known Pd biomarker for CD19 targeting therapies, will be evaluated.
		  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: Once	Occurrences: --	Comments:	Alanine aminotransferase (ALT) LESS than 2.5 × upper limit of normal (ULN) and total bilirubin LESS than 2.0 mg/dl (or LESS than 3.0 mg/dl for subjects with Gilbert's syndrome or lymphomatous infiltration of the liver), Creatinine clearance calculated from serum creatinine using the Cockcroft-Gault equation GREATER than or EQUAL to 60 mL/min. 
			Pre-Medications
  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	30-60 minutes prior to CNTY-101 infusion		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	30-60 minutes prior to CNTY-101 infusion			Chemotherapy
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	CNTY-101 (undiluted) 45e6 cells/mL. 
Doses: 30e6 (0.7mL), 100e6 (2.2mL), 300e6 (6.6mL), OR 1000e6 (22mL) cells. 
Rate: 1 mL per minute. 
Admin instructions: Uses PhaSeal connectors.  Flush line with 0.9% NaCl.
		  	INV-CNTY-101 (ELIPSE1/PRO00036989/PINGALI) ORDERABLE	Dose: --	Route: intravenous	once @ 60 mL/hr for 1 dose			Offset: 30 Minutes	Instructions:	Prepared syringe contains open label active CNTY-101. Administer as slow intravenous infusion per sponsor protocol instructions. Do not use filters. Flush with NS pre and post study drug administration. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	A. IL2 is not administered to all subjects. Please verify subject randomization.
B. IL2 if needed will be dispense by IDS using paper order. Give 4 hours after CNTY-101 infusion. Ensure patient has received pre-medication: Acetaminophen 650mg, Benadryl, and/or others 30-60 min prior to dose.
			Hypersensitivity
  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	every 6 hours PRN	Start: S			Instructions:	May be repeated every 6 hours as needed based on Investigator's assessment of symptoms, available during the 72 hours post infusion.		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	every 6 hours PRN	Start: S			Instructions:	May be repeated every 6 hours as needed based on Investigator's assessment of symptoms, available during the 72 hours post infusion.				Day 3	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION 7	Interval: Until discontinued	Occurrences: --	Comments:	Discharge: if stable, per PI assessment
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Once	Occurrences: --	Comments:	include temperature, weight, respiratory rate, heart rate, blood pressure, and SaO2 by pulse oximeter. Per unit policy/PI orders for frequency.
		  	ONC NURSING COMMUNICATION 8	Interval: Once	Occurrences: --	Comments:	ICE Score
The 10-point ICE score includes grading from 10 (no impairment), 7 to 9 (mild impairment), 3 to 6 (moderate impairment), 0 to 2 (severe impairment), and 0 due to subject unarousable and unable to perform ICE assessment. ICE scores should be measured as described in Lee et al. 201986 (see the Guidelines Addendum for additional details)
		  	ONC NURSING COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	AE/SAE Assessment
		  	ONC NURSING COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Concomitant Medications
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --			Labs
  	ABSOLUTE NEUTROPHIL COUNT	Interval: Once	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	A. IL2 is not administered to all subjects. Please verify subject randomization.
B. IL2 if needed will be dispense by IDS using paper order. Give 4 hours after CNTY-101 infusion. Ensure patient has received pre-medication: Acetaminophen 650mg, Benadryl, and/or others 30-60 min prior to dose.