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Odronextamab with Chemotherapy for Untreated DLBCL

This study is comparing a new drug, odronextamab, combined with standard chemotherapy (cyclophosphamide, doxorubicin, vincristine) against rituximab plus the same chemotherapy. It's for adults with diffuse large B-cell lymphoma (DLBCL) that hasn't been treated before. The study also includes patients whose DLBCL has returned or didn't respond to previous treatments. The main goal is to understand how safe odronextamab is and what side effects it might cause, as well as to find the best dose to use in future parts of the study. You must have CD20+ DLBCL to participate.

Study design
This is an interventional study with a planned enrollment of 904 participants. It will compare two treatment approaches: odronextamab plus chemotherapy versus rituximab plus chemotherapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track side effects for up to 2 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06091865

A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma

Recruiting
PHASE3Ages 18+InterventionalTreatment
Regeneron Pharmaceuticals
~904 participants
Updated 2026-09-14 on ClinicalTrials.gov
What's tested:OdronextamabRituximabCyclophosphamideDoxorubicinVincristinePrednisone/Prednisolone

At a glance

Recruiting sites
173 of 185 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Dose Limiting Toxicities (DLTs)
Measured over Up to 35 days
+3 more outcomes measured

Conditions

Diffuse Large B-cell Lymphoma (DLBCL)

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Where you'd take part

This study runs at 185 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • A.O.U. di Modena

    Modena, Italyno site contact published

    Recruiting

  • AC Camargo Cancer Center

    São Paulo, Brazilno site contact published

    Recruiting

  • Aidport

    Skorzewo, Wielkopolska, Polandno site contact published

    Recruiting

  • Algemeen Ziekenhuis AZ Delta

    Roeselare, West-Vlaanderen, Belgiumno site contact published

    Recruiting

  • Amaral Carvalho Hospital

    Jaú, São Paulo, Brazilno site contact published

    Recruiting

  • Animi Unidade de Tratamento Oncologico Ltda

    Lages, Santa Catarina, Brazilno site contact published

    Recruiting

  • AOU Maggiore della Carita

    Novara, Italyno site contact published

    Recruiting

  • Asan Medical Center

    Seoul, South Koreano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Clinical Trial Management · STUDY_DIRECTOR · Regeneron Pharmaceuticals

Who to contact

Clinical Trials Administrator
[email protected]
844-734-6643
Email the study team

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What this trial measures

  • Incidence of Dose Limiting Toxicities (DLTs)Up to 35 days

    Part 1A

  • Incidence of Treatment Emergent Adverse Events (TEAEs)Up to 2 years

    Part 1

  • Severity of TEAEsUp to 2 years

    Part 1

  • Progression Free Survival (PFS), assessed by Independent Central Review (ICR)Up to 5 years

    Part 2