RecruitingPhase 3NCT06230224

A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma

A Phase 3, Randomized, Open Label Study Evaluating the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, Versus Standard of Care Therapy in Participants With Relapsed/Refractory Aggressive B-cell Non-Hodgkin Lymphoma (OLYMPIA-4)

Sponsor

Regeneron Pharmaceuticals

Enrollment

216 participants

Start Date

Feb 15, 2024

Study Type

INTERVENTIONAL

Summary

This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on patients with previously treated aggressive B-cell non-Hodgkin lymphoma whose cancer has stopped responding to treatment (also known as 'refractory') or has returned (also known as 'relapsed'). The aim of the study is to see how safe, tolerable and effective the study drug is when given alone. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug versus Standard of Care (SOC) * 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) * Comparing the impact from the study drug versus SOC on quality-of-life and ability to complete routine daily activities

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing a drug called odronextamab (a bispecific antibody that helps the immune system attack cancer cells) to standard chemotherapy regimens for adults with aggressive B-cell non-Hodgkin lymphoma that has come back or did not respond to initial treatment. **You may be eligible if...** - You are an adult with a confirmed diagnosis of aggressive B-cell non-Hodgkin lymphoma - Your cancer either did not respond to initial treatment (primary refractory) or came back within 12 months of starting first-line therapy - You have received only 1 prior treatment line that included both an anti-CD20 antibody (like rituximab) and an anthracycline chemotherapy - You have at least one measurable tumor on imaging - Tumor tissue is available for submission to the central lab **You may NOT be eligible if...** - You have received more than 1 prior treatment line - Your cancer came back more than 12 months after starting initial therapy - You have active brain involvement by your lymphoma - You have significant uncontrolled medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOdronextamab

Administered by intravenous (IV) infusion

DRUGIfosfamide

Administered by IV infusion, as part of the ICE ± R salvage therapy

DRUGCarboplatin

Administered by IV infusion, as part of the ICE ± R salvage therapy

DRUGEtoposide

Administered by IV infusion, as part of the ICE ± R salvage therapy

DRUGRituximab

Administered by IV infusion, as part of the ICE ± R, or DHAP ± R, or GDP ± R salvage therapy.

DRUGDexamethasone

Administered by IV, or orally (PO) as part of the DHAP ± R, or GDP ± R salvage therapy.

DRUGCisplatin

Administered by IV infusion, as part of the DHAP ± R or GDP +/-R salvage therapy.

DRUGCytarabine

Administered by IV infusion, as part of the DHAP ± R salvage therapy.

DRUGGemcitabine

Administered by IV infusion, as part of the GDP ± R salvage therapy.