Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) (NCT04663347)
A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination With Other Agents in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
- 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)
- Epcoritamab (BIOLOGICAL)
- rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisone (DRUG)
- Lenalidomide (DRUG)
- rituximab, ifosfamide, carboplatin, and etoposide phosphate (DRUG)
- Epcoritamab (BIOLOGICAL)
- Epcoritamab (BIOLOGICAL)
- Epcoritamab (BIOLOGICAL)
- Epcoritamab (BIOLOGICAL)
- Epcoritamab (BIOLOGICAL)
- Epcoritamab (BIOLOGICAL)
- Epcoritamab (BIOLOGICAL)
- Rituximab and Lenalidomide (DRUG)
- Epcoritamab (BIOLOGICAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (57 Sites)
Showing the first 25 of 57 sites.
- University of Alabama at Birmingham — Birmingham, Alabama
- Cedars-Sinai Medical Center — Los Angeles, California
- David Geffen School of Medicine at UCLA — Los Angeles, California
- University of California San Francisco — San Francisco, California
- Dana Farber Cancer Institute — Boston, Massachusetts
- University of Michigan Comprehensive Cancer Center Michigan Medicine — Ann Arbor, Michigan
- Hackensack University Medical Center — Hackensack, New Jersey
- Mount Sinai — New York, New York
- Memorial Sloan Kettering CC — New York, New York
- Levine Cancer Center — Charlotte, North Carolina
- Southwestern Medical Center — Dallas, Texas
- 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,
- Århus Hospital — Aarhus,
- Rigshospitalet — Copenhagen,
- Odense University Hospital — Odense,
- Vejle Sygehus — Vejle,
- Kuopio University Hospital — Kuopio,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Diffuse Large B-Cell Lymphoma
- Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients — Daphne, Alabama
- A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) — Tucson, Arizona
- Testing the Addition of a New Anti-cancer Drug, Venetoclax, to Usual Chemotherapy for High Grade B-cell Lymphomas — Birmingham, Alabama
- A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312) — Tucson, Arizona
- A Study of Brentuximab Vedotin, Rituximab, and Dose Attenuated CHP in Elderly Patients With Diffuse Large B-Cell Lymphoma (DLBCL) — Rochester, New York
- Zanubrutinib in Combination With R-PolaCHP (ZaR-PolaCHP) for Newly Diagnosed Diffuse Large B-Cell Lymphoma — Cleveland, Ohio
Explore by condition: All Diffuse Large B-Cell Lymphoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.