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)
A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With R-CHOP Compared to R-CHOP in Subjects With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Arizona Cancer Center - North Campus /ID# 227463 — Tucson, Arizona
Age range: 18 Years to 79 Years
🧪 Interventions in This Study
📋 "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 (331 Sites)
Showing the first 25 of 331 sites.
- University of Arizona Cancer Center - North Campus /ID# 227463 — Tucson, Arizona
- Yuma Regional Medical Center /ID# 261527 — Yuma, Arizona
- University of Arkansas for Medical Sciences /ID# 225703 — Little Rock, Arkansas
- CBCC Global Research, Inc. /ID# 262037 — Bakersfield, California
- Alta Bates Summit Medical Center for Research /ID# 229427 — Berkeley, California
- Orange Coast Memorial Medical Center /ID# 229632 — Fountain Valley, California
- Providence - St. Jude Medical Center /ID# 262042 — Fullerton, California
- Saddleback Memorial Medical Center /ID# 229631 — Laguna Hills, California
- Long Beach Memorial Medical Ct /ID# 228996 — Long Beach, California
- Cancer and Blood Speciality Clinic - Los Alamitos /ID# 262032 — Los Alamitos, California
- University of Southern California /ID# 225443 — Los Angeles, California
- University of California, Los Angeles /ID# 226887 — Los Angeles, California
- Kaiser Permanente, Waterpark III Institute for Health Research /ID# 228618 — Aurora, Colorado
- Cancer Specialists of North Florida /ID# 226826 — Jacksonville, Florida
- Ocala Oncology Florida Cancer Affiliates - Main /ID# 262785 — Ocala, Florida
- Orlando Health Cancer Institute /ID# 232626 — Orlando, Florida
- Straub Medical Center /ID# 229464 — Honolulu, Hawaii
- University of Illinois at Chicago /ID# 226889 — Chicago, Illinois
- Southern IL Univ School of Med /ID# 228999 — Springfield, Illinois
- Springfield Clinic Main Campus /ID# 262584 — Springfield, Illinois
- Carle Cancer Institute /ID# 228338 — Urbana, Illinois
- Parkview Comprehensive Cancer Center /ID# 227026 — Fort Wayne, Indiana
- Goshen Center for Cancer Care /ID# 225534 — Goshen, Indiana
- University of Iowa Health Care /ID# 261945 — Des Moines, Iowa
- Cancer Center of Kansas /ID# 261983 — Wichita, Kansas
💰 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
- 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.