Protocol Index	

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RSH PRO00037811 NCT05578976 / SCREENING	

Types:      Research Oncology Treatment
Synonyms:  SCREENING

Screening	Repeat 1 time	Cycle length: 28 days	Day -28	Perform every 0 days x1		Provider Communication
  	ONC PROVIDER 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 Guidelins.
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Epcoritamab Treatment: Refer to Section 6.2 Toxicity Management, Dose Modifications, and Safety Management
			Nursing Orders
  	CONSENT OBTAINED	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Eligibility criteria
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Demographics
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medical/surgical history.

Demographics, history of tobacco, alcohol, and drug use, and surgical history will be taken at Screening. The subject's medical history will be updated predose at C1D1 visit.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Alcohol and nicotine use
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events assessment
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/concomitant therapy
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, pulse, respiration, oximetry, and temperature
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG Performance Standards.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Constitutional symptoms (B symptoms).

Assessment for the presence of drenching night sweats, unintentional weight loss of > 10% of body mass in the previous 6 months and/or fever > 38°C without identifiable cause
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Lymph node examination
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Neurological (ICANS) assessment
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Disease status and subtype
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Females only. Not required for females of non-CBP
		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	If needed to determine postmenopausal status
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	IMMUNOGLOBULIN A	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN G	Interval: --	Occurrences: --		  	IMMUNOGLOBULIN M	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --		  	ZZANTI-HU	Interval: --	Occurrences: --		  	EOSINOPHIL COUNT ABSOLUTE	Interval: --	Occurrences: --		  	ABSOLUTE BASOPHILS COUNT	Interval: --	Occurrences: --		  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Absolute Blast count (if present)
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	FERRITIN LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	TRIGLYCERIDES	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	FIBRINOGEN	Interval: --	Occurrences: --			Labs
  	BETA-2 MICROGLOBULIN	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --	Comments:	If positive, PCR to quantitate hepatitis B DNA or hepatitis C RNA must be performed and must be negative prior to randomization/enrollment
		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --	Comments:	If positive, PCR to quantitate hepatitis B DNA or hepatitis C RNA must be performed and must be negative prior to randomization/enrollment
		  	HEPATITIS C ANTIBODY	Interval: --	Occurrences: --	Comments:	If positive, PCR to quantitate hepatitis B DNA or hepatitis C RNA must be performed and must be negative prior to randomization/enrollment
			Labs
  	COVID-19 QUALITATIVE RT-PCR	Interval: --	Occurrences: --	Comments:	Only if a subject has signs/symptoms suggestive of SARS-CoV-2 or as deemed necessary by the investigator molecular (e.g., PCR) test or 2 negative antigen test results at least 24 hours apart.
		  	TB SKIN TEST	Interval: --	Occurrences: --	Comments:	IGRA
Tuberculosis screening for suspected active or latent TB (if clinically indicated)
		  	CYTOMEGALOVIRUS BY PCR	Interval: --	Occurrences: --	Comments:	For subjects with a positive screening CMV PCR test that has not demonstrated viral clearance prior to C1D1, or for all subjects whose PCR test becomes positive at any time, then the CMV DNA PCR test should be repeated more frequently and CMV treatment initiated or continued as appropriate, per investigator's discretion and institutional SOC.
			Labs
  	CYTOMEGALOVIRUS AB, IGM	Interval: --	Occurrences: --		  	CYTOMEGALOVIRUS AB, IGG	Interval: --	Occurrences: --			Imaging
  	TTE COMPLETE, WO CONTRAST, WO DOPPLER	Interval: --	Occurrences: --		  	ZZ_HIST_NM CARDIAC BLOOD POOL MUGA (AT REST)	Interval: --	Occurrences: --			Imaging
  	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	PET/CT

PET-CT with contrast enhancement is required. If the CT component of the PET-CT scan is not of diagnostic quality, a standalone, contrast-enhanced CT or MRI scan is required.  CT coverage of the neck, chest, abdomen, pelvis, and any other disease sites is required.
		  	MRI WHOLE BODY WO	Interval: --	Occurrences: --	Comments:	CT with contrast enhancement is required. If the CT component of the PET-CT scan is not of diagnostic quality, a standalone, contrast-enhanced CT or MRI scan is required.  CT coverage of the neck, chest, abdomen, pelvis, and any other disease sites is required.
		  	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Brain MRI/CECT and lumbar puncture for subjects with high-risk for CNS involvement or as clinically indicated. Local flow cytometry (preferred) or cytology and CSF samples sent centrally
			Imaging
  	PET CT WHOLE BODY	Interval: --	Occurrences: --	Comments:	CECT - whole body.

PET-CT with contrast enhancement is required. If the CT component of the PET-CT scan is not of diagnostic quality, a standalone, contrast-enhanced CT or MRI scan is required.  CT coverage of the neck, chest, abdomen, pelvis, and any other disease sites is required.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECG to be obtained prior to the blood collection.  ECGs occurring near meals will take place prior to meals. Acquired after the subject has been in the supine position for at least 5 minutes
			Procedures
  	BIOPSY	Interval: --	Occurrences: --	Comments:	Tumor biopsy:

If archival tissue (20 FFPE Slides or block) is unavailable or inadequate, tumor tissue must be obtained from a biopsy performed at screening
			Appointment Requests
  	IR LUMBAR PUNCTURE	Interval: --	Occurrences: --	Comments:	Collect prior to any intrathecal MTX (on or after C5D1)
			Pharmacokinetic Instructions
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Only for subjects deemed to be at high-risk for CNS relapse at baseline
Screening (when lumber puncture is indicated to rule out CNS involvement)
Prior to any intrathecal MTX administration (on or after C5D1)
Any subject for whom a lumber puncture is performed during the study for CNS disease work-up
As clinically indicated.
				Day -2	Perform every 1 day x1		Labs
  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Local laboratory values for CBC, chemistry and coagulation must be obtained within
2 days prior to the first study drug administration and reviewed by the Investigator prior to the first study drug administration to ensure that the subject is still eligible
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --		  	ZZANTI-HU	Interval: --	Occurrences: --		  	EOSINOPHIL COUNT ABSOLUTE	Interval: --	Occurrences: --		  	ABSOLUTE BASOPHILS COUNT	Interval: --	Occurrences: --		  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Absolute Blast count (if present)
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	FERRITIN LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	TRIGLYCERIDES	Interval: --	Occurrences: --