A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma (NCT06097364)
A Phase 3, Open-Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20x Anti-CD3 Bispecific Antibody, Combined With Chemotherapy Versus Rituximab Combined With Chemotherapy in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-2)
🩺 Plain-English Summary (8th-Grade Level)
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. Follicular lymphoma is a type of non-Hodgkin lymphoma or NHL. Participants with follicular lymphoma that has come back after treatment (called "relapsed") or did not respond to treatment (called "refractory") are eligible to take part only in Part 1A of the study. This study is made up of 3 parts: Part 1A (non-randomized), Part 1B and Part 2 (randomized - controlled). 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 to be used in Part 2 of the study. The aim of Part 2 of the study is to assess how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab 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) * 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: Boca Raton Clinical Research (BRCR) Global — Plantation, Florida
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 (145 Sites)
Showing the first 25 of 145 sites.
- Boca Raton Clinical Research (BRCR) Global — Plantation, Florida
- Investigative Clinical Research of Indiana — Noblesville, Indiana
- Cancer Center of Kansas — Wichita, Kansas
- University of Kentucky — Lexington, Kentucky
- Henry Ford Health System — Detroit, Michigan
- Cancer and Hematology Centers of Western Michigan — Grand Rapids, Michigan
- 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
- Pindara Private Hospital — Benowa, Queensland
- Karl Landsteiner University Hospital St. Poelten — Sankt Pölten, Lower Austria
- Medical University of Graz — Graz, Styria
- Landeskrankenhaus Hochsteiermark — Leoben, Styria
- Innsbruck Medical University — Innsbruck, Tyrol
- Kepler University Hospital — Linz, Upper Austria
- Universitatsklinik fur Kinder und Jungendheilkunde — Vienna,
- Klinikum Wels-Grieskirchen — Wels,
- Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital — Ghent, Oost-Vlaanderen
- Verenigde Ziekenhuizen van Waas en Durme — Sint-Niklaas, Oost-Vlaanderen
- Algemeen Ziekenhuis St Jan Brugge Oostende Av — Bruges, West-Vlaanderen
- AZ Groeninge — Kortrijk, West-Vlaanderen
- Institut Jules Bordet — Brussels,
- Centre Hospitalier Regional de la Citadelle — Liège,
💰 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 Follicular Lymphoma (FL)
- A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma — Camperdown, New South Wales
- Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma — Fresno, California
- Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma — Tucson, Arizona
- 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 — Tucson, Arizona
Explore by condition: All Follicular Lymphoma (FL) 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.