A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma (NCT06091865)
A Phase 3, Open Label, Randomized Study Comparing the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 × Anti-CD3 Bispecific Antibody, in Combination With CHOP (ODRO-CHOP) Versus Rituximab in Combination With CHOP (R-CHOP) in Previously Untreated Participants With Diffuse Large B-cell Lymphoma (DLBCL) (OLYMPIA-3)
🩺 Plain-English Summary (8th-Grade Level)
This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy. The study is focused on patients with Diffuse Large B-cell Lymphoma (DLBCL) that have not been treated before (called "previously untreated"). Patients with DLBCL that have come back after treatment (called "relapsed"), or have not responded to treatment (called "refractory"), can also participate in this study. This study will be made up of Part 1A, Part 1B, and Part 2.The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy in Part 2 of the study. The aim of Part 2 of the study is to see how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab (the comparator drug), and chemotherapy, the current standard of care treatment approved for DLBCL. Standard of care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug when combined with chemotherapy * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) * The impact from the study drug on quality of life and ability to complete routine daily activities
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic - Arizona — Scottsdale, Arizona
Age range: 18 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 (178 Sites)
Showing the first 25 of 178 sites.
- Mayo Clinic - Arizona — Scottsdale, Arizona
- David Geffen School of Medicine at UCLA — Los Angeles, California
- University of California Irvine Medical Center — Orange, California
- University of California (UC) Davis — Sacramento, California
- Mayo Clinic Jacksonville — Jacksonville, Florida
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis, Indiana
- St Vincent Ascension at Peyton Manning Childrens Hospital — Indianapolis, Indiana
- Investigative Clinical Research of Indiana — Noblesville, Indiana
- University of Kentucky — Lexington, Kentucky
- University of Maryland Greenebaum Comprehensive Cancer Center — Baltimore, Maryland
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- Henry Ford Health System — Detroit, Michigan
- Cancer and Hematology Centers of Western Michigan — Grand Rapids, Michigan
- Mayo Clinic - Rochester — Rochester, Minnesota
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey
- Stony Brook University Hospital — Stony Brook, New York
- Clinical Research Alliance Inc — Westbury, New York
- Duke University Medical Center — Durham, North Carolina
- East Carolina University — Greenville, North Carolina
- University Hospitals Cleveland Medical Center — Cleveland, Ohio
- Center for Oncology and Blood Disorders — Houston, Texas
- Community Cancer Trials of Utah — Ogden, Utah
- Prohealth Care Inc — Waukesha, Wisconsin
- Liverpool Hospital — Liverpool, New South Wales
- Calvary Mater Newcastle — Waratah, New South Wales
📞 Contact the Study Coordinator
Phone: (844) 734-6643
Email: clinicaltrials@regeneron.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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 (DLBCL)
- Study of the Impact of CD34+ Cell Dose on Absolute Lymphocyte Count Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL) — Omaha, Nebraska
- Autologous IC-Nine, CD30 CAR, and Constitutive IL7R Expressing EBVST for CD30 Lymphoma (ANCILE-30) — Houston, Texas
- The CARDIOPROTECT Trial — Boston, Massachusetts
- A Study to Evaluate the Impact of Mosunetuzumab Consolidation for Older Patients With Diffuse Large B-cell Lymphoma (DLBCL) Who Have Detectable Amounts of ctDNA (Circulating Tumor DNA) at the End of Treatment With Pola-R-mini-CHP — Rochester, New York
Explore by condition: All Diffuse Large B-cell Lymphoma (DLBCL) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.