A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma
Public ClinicalTrials.gov record NCT06091254. 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 to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 X Anti-CD3 Bispecific Antibody Versus Investigator's Choice in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-1)
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. The study is focused on participants with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma or NHL). This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is when given alone. The aim of Part 2 of the study is to see how the study drug works compared to rituximab (called the "comparator drug") and chemotherapy (the current standard of care for NHL). 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 * 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) * How the study drug affects quality of life and ability to complete routine daily activities.
Study identification
- NCT ID
- NCT06091254
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 822 participants
Conditions and interventions
Conditions
Interventions
- Odronextamab Drug
- Rituximab Drug
- Cyclophosphamide Drug
- Doxorubicin Drug
- Vincristine Drug
- Prednisone/prednisolone Drug
- Bendamustine 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 11, 2023
- Primary completion
- Feb 6, 2028
- Completion
- Nov 2, 2029
- Last update posted
- Aug 9, 2026
2023 – 2029
United States locations
- U.S. sites
- 20
- U.S. states
- 14
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arizona Cancer Center | Tucson | Arizona | 85724 | Recruiting |
| David Geffen School of Medicine at UCLA | Los Angeles | California | 90095 | Recruiting |
| UC Irvine Health | Orange | California | 92868 | Withdrawn |
| Investigative Clinical Research of Indiana | Noblesville | Indiana | 46062 | Recruiting |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | Recruiting |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | Recruiting |
| Hattiesburg Clinic | Hattiesburg | Mississippi | 39401 | Completed |
| Icahn School of Medicine at Mt Sinai | New York | New York | 10029 | Recruiting |
| Stony Brook University Hospital | Stony Brook | New York | 11794 | Recruiting |
| Clinical Research Alliance Inc | Westbury | New York | 11590 | Withdrawn |
| University of North Carolina | Chapel Hill | North Carolina | 27514 | Recruiting |
| Levine Cancer Institute | Charlotte | North Carolina | 28207 | Recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | Recruiting |
| Center for Oncology and Blood Disorders | Houston | Texas | 77030 | Recruiting |
| HOPE Cancer Center of East Texas | Tyler | Texas | 75701 | Withdrawn |
| Huntsman Cancer Institute - Oncology Division | Salt Lake City | Utah | 84112 | Recruiting |
| University of Virginia | Charlottesville | Virginia | 22908 | Recruiting |
| Virginia Commonwealth University | Richmond | Virginia | 23219 | Withdrawn |
| 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 169 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06091254, 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 9, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06091254 live on ClinicalTrials.gov.