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NCT06097364 · ClinicalTrials.gov record · last posted 2026-02-06

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

Study acronym: OLYMPIA-2
StatusActive, Not Recruiting
PhasePhase 3
Started2023-11-14
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from the ClinicalTrials.gov record
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

Amendment record 34 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 34 times since 2023-10-18; most recent amendment 2026-02-04. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2025-09-18
Status change RecruitingActive, Not Recruitingv33
Trial Details
NCT Number NCT06097364
Lead Sponsor Regeneron Pharmaceuticals
Conditions Follicular Lymphoma (FL)
Enrollment 733 participants
Start Date 2023-11-14
Primary Completion 2029-07-29 (estimated)
Study Completion 2029-07-29 (estimated)
Updated on ClinicalTrials.gov 2026-02-06