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Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)
NCT04663347 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 543 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genmab, which has 59 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Follicular Lymphoma appearing as the primary indexed condition, and to 5 interventions — of which rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04663347 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, California, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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: Follicular Lymphoma, Diffuse Large B-Cell Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04663347?
This trial is sponsored by Genmab, which has 59 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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