Recruiting

Phase 3

Odronextamab vs. RituximabA 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

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT06091254

Conditions

Follicular Lymphoma (FL)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Odronextamab

Rituximab

Cyclophosphamide

Doxorubicin

Vincristine

Study Details

Brief summary:

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.

Conditions

Follicular Lymphoma (FL)

Study ID

NCT06091254

Start date

Dec 12, 2023

Status verified date

Aug, 2026

Completion date

Nov 3, 2029

Anticipated

Primary completion date

Feb 7, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

1. Diagnosis of Cluster of Differentiation 20\^+ (CD20\^+) FL Grade 1-3a, stage II bulky or stage III / IV
2. Need for treatment as described in the protocol
3. Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
5. Adequate bone marrow function and hepatic function, as described in the protocol

Key Exclusion Criteria:

1. Central Nervous System (CNS) lymphoma or leptomeningeal lymphoma
2. Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
3. Waldenström Macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma
4. Treatment with any systemic anti-lymphoma therapy
5. Infections and allergy/hypersensitivity to study drug or excipient, as described in the protocol

NOTE: Other protocol defined inclusion/exclusion criteria apply

Study Design

Enrollment

822 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Odronextamab

Part 1 is a safety run-in. All participants will receive odronextamab.

In part 2 participants will be randomly assigned in a 1:1 ratio to receive odronextamab followed by odronextamab maintenance.

active comparator: Rituximab + Investigator's Choice Chemotherapy

Part 2 only, participants will be randomized 1:1 to receive rituximab in combination with chemotherapy followed by rituximab maintenance.

Interventions

Odronextamab

Administered per the protocol

Rituximab

Administered per the protocol

Cyclophosphamide

Administered per the protocol as part of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) chemotherapy, or Cyclophosphamide, Vincristine, Prednisone (CVP) chemotherapy

Doxorubicin

Administered per the protocol as part of CHOP chemotherapy

Vincristine

Administered per the protocol as part of CHOP, and CVP chemotherapy

Prednisone/prednisolone

Administered per the protocol as part of CVP chemotherapy

Bendamustine

Administered per the protocol as part of chemotherapy (Rituximab-Bendamustine)

Primary outcome measure

Incidence of Dose-Limiting Toxicities (DLTs) for odronextamab [ Time Frame: Up to 35 days ]
Incidence of Treatment-Emergent Adverse Events (TEAEs) of odronextamab [ Time Frame: Up to 2 years ]
Severity of TEAEs of odronextamab [ Time Frame: Up to 2 years ]
Complete Response at 30 months (CR30) as assessed by independent central review [ Time Frame: Up to 30 months ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643 clinicaltrials@regeneron.com

Locations

University of Arizona Cancer Center

Recruiting

Tucson, Arizona, United States, 85724

David Geffen School of Medicine at UCLA

Recruiting

Los Angeles, California, United States, 90095

Investigative Clinical Research of Indiana

Recruiting

Noblesville, Indiana, United States, 46062

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Icahn School of Medicine at Mt Sinai

Recruiting

New York, New York, United States, 10029

Stony Brook University Hospital

Recruiting

Stony Brook, New York, United States, 11794

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27514

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28207

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Center for Oncology and Blood Disorders

Recruiting

Houston, Texas, United States, 77030

Huntsman Cancer Institute - Oncology Division

Recruiting

Salt Lake City, Utah, United States, 84112

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Tom Baker Cancer Center

Recruiting

Calgary, Alberta, Canada, T2N 4J8

Saint John Regional Hospital

Recruiting

Saint John, New Brunswick, Canada, E2L 4L2

Centre Integre de Sante et de Services Sociaux (CISSS) de la Monteregie-Centre

Recruiting

Greenfield Park, Quebec, Canada, J4V 2H1

CHU de Quebec - Universite Laval

Recruiting

Québec, Quebec, Canada, G1J1Z4

Ciusss de Lestrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS)

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

Non-Hodgkin lymphomas (NHLs)
Indolent NHL
B-cells NHL (B-NHL)
Follicular lymphoma
Odronextamab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-08-10.