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OncoMatch/Clinical Trials/NCT06091254

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

Is NCT06091254 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for follicular lymphoma (fl).

Phase 3RecruitingRegeneron PharmaceuticalsNCT06091254Data as of May 2026

Treatment: Odronextamab · Rituximab · Cyclophosphamide · Doxorubicin · Vincristine · Prednisone/prednisolone · BendamustineThis 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.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Biomarker criteria

Required: MS4A1 overexpression (CD20+)

Diagnosis of Cluster of Differentiation 20^+ (CD20^+) FL

Disease stage

Required: Stage II BULKY, III, IV

Grade: 123a

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic anti-lymphoma therapy

Lab requirements

Blood counts

adequate bone marrow function, as described in the protocol

Liver function

adequate hepatic function, as described in the protocol

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Arizona Cancer Center · Tucson, Arizona
  • David Geffen School of Medicine at UCLA · Los Angeles, California
  • UC Irvine Health · Orange, California
  • Investigative Clinical Research of Indiana · Noblesville, Indiana
  • Beth Israel Deaconess Medical Center · Boston, Massachusetts

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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