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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)
NCT05578976 · View on ClinicalTrials.gov ↗
Study Summary
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) or R-CHOP in adult participants globally with diffuse large b-cell lymphoma (DLBCL). Change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in groups called treatment arms. Participants will receive epcoritamab combined with R-CHOP, followed by epcoritamab or R-CHOP followed by rituximab will be explored. Approximately 900 adult participants with with newly diagnosed DLBCL will be enrolled in the study in approximately 315 sites in globally. In the Arm 1, participants will receive subcutaneous epcoritamab combined with intravenous and oral R-CHOP followed by subcutaneous epcoritamab in 21-day cycles. In the Arm 2, participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Epcoritamab
- DRUG Rituximab
- DRUG Vincristine
Study Locations (20)
California
- CBCC Global Research, Inc. /ID# 262037 — Bakersfield
- Alta Bates Summit Medical Center for Research /ID# 229427 — Berkeley
- Orange Coast Memorial Medical Center /ID# 229632 — Fountain Valley
- Providence - St. Jude Medical Center /ID# 262042 — Fullerton
- Saddleback Memorial Medical Center /ID# 229631 — Laguna Hills
- Long Beach Memorial Medical Ct /ID# 228996 — Long Beach
- Cancer and Blood Speciality Clinic - Los Alamitos /ID# 262032 — Los Alamitos
- University of Southern California /ID# 225443 — Los Angeles
- University of California, Los Angeles /ID# 226887 — Los Angeles
Florida
- Cancer Specialists of North Florida /ID# 226826 — Jacksonville
- Ocala Oncology Florida Cancer Affiliates - Main /ID# 262785 — Ocala
- Orlando Health Cancer Institute /ID# 232626 — Orlando
Illinois
- University of Illinois at Chicago /ID# 226889 — Chicago
- Southern IL Univ School of Med /ID# 228999 — Springfield
- Springfield Clinic Main Campus /ID# 262584 — Springfield
Arizona
- University of Arizona Cancer Center - North Campus /ID# 227463 — Tucson
- Yuma Regional Medical Center /ID# 261527 — Yuma
Arkansas
- University of Arkansas for Medical Sciences /ID# 225703 — Little Rock
Colorado
- Kaiser Permanente, Waterpark III Institute for Health Research /ID# 228618 — Aurora
Hawaii
- Straub Medical Center /ID# 229464 — Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 900 participants |
| Start Date | 2023-02-08 |
| Est. Completion | 2029-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05578976
The ClinicalTrials.gov registry entry for NCT05578976 describes a study currently listed as active not recruiting. It is categorized as Phase 3, 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 900 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 1 condition, with Diffuse Large B-Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions — of which Cyclophosphamide 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: NCT05578976 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Illinois. 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 NCT05578976 about?
NCT05578976 is a clinical study titled "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)". B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin h...
What is the current status of trial NCT05578976?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 900 participants. The study started on 2023-02-08. Estimated completion is 2029-12.
What conditions does trial NCT05578976 study?
This clinical trial studies the following conditions: 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 NCT05578976?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Epcoritamab (DRUG), Rituximab (DRUG), Vincristine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05578976?
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 NCT05578976 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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