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1 Study Matches

PSCI-22-042: A Phase 2, Open Label Trial to Evaluate Safety of Epcoritamab monotherapy in Subjects with Relapsed or Refractory B Cell Non Hodgkin Lymphoma when Administered in the Outpatient Setting

The purpose of this voluntary research study is to optimize the approach to safely administer a study drug called epcoritamab in the outpatient/non-hospital setting.

Complete interview, questionnaires, and subject diary ECG Clinical laboratory tests Biopsy sample, archival or fresh CT/PET-CT/MRI Treatment of epcoritamab

Seema Naik
Laurie ONeal - at loneal1@pennstatehealth.psu.edu or 717-531-0003, ext=343429
 

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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05451810
SITE00001234
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Inclusion Criteria:
Subjects must voluntarily sign and date an informed consent,
Adult male or female, at least 18 years old
Diagnosis of R/R DLBCL or R/R FL grade 1, 2, or 3a, with documented CD20+ mature B-cell neoplasm according to WHO classification 2016 or WHO classification 2008 based on representative pathology report
Subject must have 1 or more measurable disease sites:  Fluorodeoxyglucose (FDG)-avid lymphomas:
Subject must have Eastern Cooperative Oncology Group (ECOG) performance status 0 – 2
Exclusion Criteria:
Central nervous system (CNS) involvement
inadequate organ functions
central nervous system involvement
history of primary mediastinal lymphoma.
history of severe allergic or anaphylactic reactions to anti-CD20 monoclonal antibody therapy.
Cancer
Not applicable
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See this study on ClinicalTrials.gov
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Location Contacts
Hershey, PA ,