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OP RSH PRO00038360 / PINGALI JCAR017-FOL-001 SCREENING	

Types:      Research Oncology Treatment
Synonyms:  

Baseline / Screening - Before Leukapheresis	Repeat 1 time	Cycle length: 14 days	Baseline / Screening - Before Leukapheresis	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION	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.
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for JCAR017 Treatment: Refer to Section 7.1.1.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Informed Consent
- Obtained any time before any study related procedure (ICF).
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Inclusion / Exclusion Criteria
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	IRT Registration
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Complete Medical History
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Demographics
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	FLIPI (Follicular Lymphoma International Prognostic Index)
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Modified GELF Criteria (GELF = Groupe d'Etude des Lymphomas Folliculaires
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	ECOG
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Physical Examination
- See Section 6.5.1 for more information about physical exams.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Routine Neurologic Examination
- A routine neurologic examination should include, at minimum, a physical exam to assess cranial nerves, motor and sensory skills, coordination and balance. Neurologist not required.
- See Section 6.5.5 for more information about neurological exams.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Including blood pressure, temperature, respiratory rate, and heart rate, oxygen saturation via pulse oximetry.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Adverse Events
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Concomitant Medications
			Labs
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	For Labs, see APPENDIX D for details.
			Labs
  	CSF CELL COUNT WITH DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	- Assessment required only for subjects with suspected or confirmed CNS involvement or as clinically indicated. Assessment not required for subjects in CR if no suspicion of CNS relapse and after PD/relapse.
- CSF assessment required by lumbar puncture or Ommaya reservoir tap in case of clinical suspicion or confirmed CNS involvement or as clinically indicated.
		  	HLA ANTIBODY TESTING	Interval: --	Occurrences: --	Comments:	Only for subjects with prior allogeneic HSCT.
		  	HLA SPECIMEN	Interval: --	Occurrences: --	Comments:	Only for subjects with prior allogeneic HSCT.
		  	ANTI-SARS-COV-2 TOTAL	Interval: --	Occurrences: --	Comments:	Anti-SARS-CoV-2 serology will be collected approximately 4 weeks after confirmed or suspected COVID-19 infection. These assessments are not required for subjects from the Cohort 3 Extension.
			Labs
  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --			Labs
  	HEPATITIS C VIRUS (HCV) ANTIBODY WITH REFLEX TO PCR	Interval: --	Occurrences: --			Labs
  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	FIBRINOGEN	Interval: --	Occurrences: --			Labs
  	D-DIMER	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	URIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	TRIGLYCERIDES	Interval: --	Occurrences: --			Labs
  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --			Labs
  	FERRITIN LEVEL	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Only for subjects from the Cohort 3 Extension.
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --		  	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	Does not need to be repeated if already performed within 4 weeks of determination of eligibility.
		  	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	- Assessment required only for subjects with suspected or confirmed CNS involvement or as clinically indicated. Assessment not required for subjects in CR if no suspicion of CNS relapse and after PD/relapse.
- PET and CT/MRI assessments do not need to be repeated if performed within 30 days before confirmation of eligibility.
		  	PET/CT BRAIN METABOLIC EVAL	Interval: --	Occurrences: --	Comments:	PET and CT/MRI assessments do not need to be repeated if performed within 30 days before confirmation of eligibility.
			Imaging
☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --		☑	CT SOFT TISSUE NECK W CONTRAST	Interval: --	Occurrences: --		☐	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --		☐	CT SOFT TISSUE NECK WO CONTRAST	Interval: --	Occurrences: --		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --		☐	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --		☐	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --		☐	MRI NECK SOFT TISSUE W WO CONTRAST	Interval: --	Occurrences: --		☐	MRI NECK SOFT TISSUE ONLY WO CONTRAST	Interval: --	Occurrences: --			Procedures
  	BIOPSY BONE MARROW	Interval: --	Occurrences: --	Comments:	For efficacy evaluations for Cohort 3 Extension.
- If a Bone Marrow Biopsy was done as standard of care procedure after the most recent relapse and a pathology report is available, the Bone Marrow Biopsy does not need to be repeated at screening.
		  	BIOPSY	Interval: --	Occurrences: --	Comments:	Gastric biopsy for gastric MALT lymphoma subjects.
		  	BIOPSY	Interval: --	Occurrences: --	Comments:	Tumor biopsy