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
Public ClinicalTrials.gov record NCT06091865. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT06091865
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 904 participants
Conditions and interventions
Conditions
Interventions
- Odronextamab Drug
- Rituximab Drug
- Cyclophosphamide Drug
- Doxorubicin Drug
- Vincristine Drug
- Prednisone/Prednisolone Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 12, 2023
- Primary completion
- Mar 29, 2028
- Completion
- Sep 11, 2029
- Last update posted
- Aug 19, 2026
2023 – 2029
United States locations
- U.S. sites
- 23
- U.S. states
- 16
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic - Arizona | Scottsdale | Arizona | 85259 | Recruiting |
| David Geffen School of Medicine at UCLA | Los Angeles | California | 90095 | Recruiting |
| University of California Irvine Medical Center | Orange | California | 92868 | Recruiting |
| University of California (UC) Davis | Sacramento | California | 95817 | Recruiting |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | Recruiting |
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center | Indianapolis | Indiana | 46202 | Recruiting |
| St Vincent Ascension at Peyton Manning Childrens Hospital | Indianapolis | Indiana | 46260 | Recruiting |
| Investigative Clinical Research of Indiana | Noblesville | Indiana | 46062 | Recruiting |
| University of Kentucky | Lexington | Kentucky | 40536 | Recruiting |
| University of Maryland Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | 21201 | Recruiting |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | Recruiting |
| Henry Ford Health System | Detroit | Michigan | 48202 | Recruiting |
| Cancer and Hematology Centers of Western Michigan | Grand Rapids | Michigan | 49503 | Recruiting |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55901 | Recruiting |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | Recruiting |
| Stony Brook University Hospital | Stony Brook | New York | 11794 | Recruiting |
| Clinical Research Alliance Inc | Westbury | New York | 11590 | Withdrawn |
| Duke University Medical Center | Durham | North Carolina | 27710 | Recruiting |
| East Carolina University | Greenville | North Carolina | 27834 | Recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | Recruiting |
| Center for Oncology and Blood Disorders | Houston | Texas | 77030 | Withdrawn |
| Community Cancer Trials of Utah | Ogden | Utah | 84405 | Recruiting |
| Prohealth Care Inc | Waukesha | Wisconsin | 53188 | Withdrawn |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 155 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06091865, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 19, 2026 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06091865 live on ClinicalTrials.gov.