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)
🩺 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: To join this study, participants generally need to meet the listed inclusion criteria (15 items) and avoid the listed exclusions (3 items).
Location: University of Arizona Cancer Center - North Campus /ID# 227463 — Tucson, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- History of prior systemic anti-lymphoma therapy for diagnosed diffuse large b-cell lymphoma (DLBCL) including any definitive radiotherapy with curative intent\] other than corticosteroids with or without vincristine during prephase treatment, or non-curative intent palliative radiotherapy with the stipulation that radiated lesions cannot be selected as target lesion for response assessment.
- Clinically significant cardiovascular disease as per the protocol.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (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.