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Testing a new drug with chemotherapy for follicular lymphoma

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)

Phase 3 Interventional Regeneron Pharmaceuticals · NCT06097364

This study is testing a new drug called odronextamab combined with chemotherapy to see if it works better and is safe for adults with follicular lymphoma compared to the standard treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment733 (estimated)
Ages18 Years and up
SexAll
SponsorRegeneron Pharmaceuticals Industry-sponsored
Drugs / interventionsodronextamab, rituximab, chemotherapy
Locations107 sites (Noblesville, Indiana and 106 other locations)
Trial IDNCT06097364 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and effectiveness of an experimental drug called odronextamab when combined with chemotherapy in adults with follicular lymphoma. The study is divided into three parts: the first part assesses the safety and tolerability of the drug, while the second part compares its effectiveness against the standard treatment of rituximab combined with chemotherapy. Participants must have a specific type of follicular lymphoma and meet certain health criteria to be eligible for the trial.

Who should consider this trial

Good fit: Ideal candidates are adults with previously untreated follicular lymphoma who meet specific diagnostic and health criteria.

Not a fit: Patients with central nervous system lymphoma or those who have transformed to a high-grade lymphoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with follicular lymphoma.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific combination is being tested for the first time.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. Have diagnosis of cluster of differentiation 20 positive (CD20+) FL grade 1-3a, stage II bulky or stage III / IV

   1. For Part 1A: previously untreated participants who have Follicular Lymphoma International Prognostic Index (FLIPI)-1 score of 3 to 5, or R/R FL
   2. For Part 1B: previously untreated participants who have FLIPI-1 score of 3 to 5
   3. For Part 2: previously untreated participants who have FLIPI-1 score of 0 to 5
2. Have measurable disease on cross sectional imaging documented by diagnostic computed tomography \[CT\], or magnetic resonance imaging \[MRI\] imaging, as described in the protocol
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
4. Adequate bone marrow and hepatic function.

Key Exclusion Criteria:

1. Participants with central nervous system lymphoma or leptomeningeal lymphoma
2. Participants with histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
3. Participants with Waldenström macroglobulinemia (WM, lymphoplasmacytic lymphoma), grade 3b follicular lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma
4. Recent major surgery and history or organ transplantation
5. A malignancy other than NHL unless the participant is adequately and definitively treated and any other significant active disease or medical condition that could interfere with the conduct of the study or put the participant at significant risk, as described in the protocol.

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Where this trial is running

Noblesville, Indiana and 106 other locations

+57 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Follicular LymphomaNon-Hodgkin lymphomasRelapsed or Refractory FLB-cells NHLUntreated FLOdronextamab
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.