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NCT04663347 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)
A Phase 1 study of Diffuse Large B Cell Lymphoma and Follicular Lymphoma, sponsored by Genmab.
- Active
- Registry status
- Phase 1
- Development phase
- 543
- Enrollment target
- 20
- Study locations
NCT04663347 is a Phase 1 study of Diffuse Large B Cell Lymphoma and Follicular Lymphoma that is active but no longer recruiting, run by Genmab. The registered enrollment target is 543 participants, above the 214-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (154% higher). The trial reports 20 study locations across 9 states.
The verdict
NCT04663347, a Phase 1 study of Diffuse Large B Cell Lymphoma and Follicular Lymphoma, is active but no longer recruiting, sponsored by Genmab.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 543 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this trial is to measure the safety and effectiveness of epcoritamab (EPKINLY™), either by itself or together with other therapies, when treating participants with B-cell non-Hodgkin Lymphoma (B-NHL). The aim of the first part of the trial is to identify the most appropriate dose of epcoritamab, and the aim of the second part of the trial is to assess the selected epcoritamab dose in a larger group of participants with B-NHL. All participants in this trial will receive either epcoritamab alone, or epcoritamab combined with another standard treatment regimen, with a total of 10 different treatment arms being studied. Trial details include: * The treatment duration for each participant depends upon which arm of treatment they are assigned to. * The visit frequency for each participant depends upon which arm of treatment they are assigned to, but will be weekly to start for all participants, then will decrease to either: every 2 weeks, or every 3 weeks, or every 4 weeks, or every 8 weeks. * All participants will receive active drug; no one will be given placebo. Participants who receive treatment with epcoritamab will have it injected right under the skin. Participants will receive a different regimen of epcoritamab depending upon which arm of treatment they are assigned. Participants who receive standard treatments will have intravenous (IV) infusions and/or oral administration of those treatments. Participants will receive a different standard treatment regimen depending upon which arm of treatment they are assigned.
Conditions Studied
Interventions
- DRUG rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
- DRUG rituximab and lenalidomide
- DRUG rituximab and bendamustine
- DRUG rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin
- DRUG gemcitabine and oxaliplatin
Study Locations (20)
Other
- Austin Health - Heidelberg
- Linear Clinical Research Limited - Nedlands
- AZ Sint-Jan - Bruges
- Universitair Ziekenhuis Gent - Ghent
- CHU UCL Namur Site Godinne - Yvoir
- Fakultni nemocnice Hradec Kralove - Hradec Králové
- Fakultni nemocnice Ostrava - Ostrava - Poruba
- Fakultni nemocnice v Motole - Prague
- Vseobecna Fakultni Nemocnice - Prague
California
- Cedars-Sinai Medical Center - Los Angeles
- David Geffen School of Medicine at UCLA - Los Angeles
- University of California San Francisco - San Francisco
New York
- Mount Sinai - New York
- Memorial Sloan Kettering CC - New York
Alabama
- University of Alabama at Birmingham - Birmingham
Massachusetts
- Dana Farber Cancer Institute - Boston
Michigan
- University of Michigan Comprehensive Cancer Center Michigan Medicine - Ann Arbor
New Jersey
- Hackensack University Medical Center - Hackensack
North Carolina
- Levine Cancer Center - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 543 participants |
| Start Date | 2020-11-03 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04663347
The ClinicalTrials.gov registry entry for NCT04663347 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 543 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 214-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (154% higher). The listed sponsor is Genmab, which has 45 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone is the first listed.
NCT04663347 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, California, New York.
Frequently Asked Questions
What is clinical trial NCT04663347 about?
NCT04663347 is a clinical study titled "Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)". The purpose of this trial is to measure the safety and effectiveness of epcoritamab (EPKINLY™), either by itself or together with other therapies, when treating participants with B-cell non-Hodgkin Lymphoma (B-NHL). The aim of the first part of the trial is to identify the most appropriate dose of e...
What is the current status of trial NCT04663347?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 543 participants. The study started on 2020-11-03. Estimated completion is 2027-09-30.
What conditions does trial NCT04663347 study?
This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma, Follicular Lymphoma.
What interventions are being tested in trial NCT04663347?
The interventions under investigation include: rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (DRUG), rituximab and lenalidomide (DRUG), rituximab and bendamustine (DRUG), rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin (DRUG), gemcitabine and oxaliplatin (DRUG).
Who is sponsoring clinical trial NCT04663347?
This trial is sponsored by Genmab, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04663347 being conducted?
This trial has 20 study locations across Alabama, California, Massachusetts, Michigan, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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