NCT06230224

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• B-Cell Non-Hodgkin Lymphoma (B-NHL)

Interventions

Type	Name	Description
DRUG	Odronextamab	Administered by intravenous (IV) infusion
DRUG	Ifosfamide	Administered by IV infusion, as part of the ICE ± R salvage therapy
DRUG	Carboplatin	Administered by IV infusion, as part of the ICE ± R salvage therapy
DRUG	Etoposide	Administered by IV infusion, as part of the ICE ± R salvage therapy
DRUG	Rituximab	Administered by IV infusion, as part of the ICE ± R, or DHAP ± R, or GDP ± R salvage therapy.
DRUG	Dexamethasone	Administered by IV, or orally (PO) as part of the DHAP ± R, or GDP ± R salvage therapy.
DRUG	Cisplatin	Administered by IV infusion, as part of the DHAP ± R or GDP +/-R salvage therapy.
DRUG	Cytarabine	Administered by IV infusion, as part of the DHAP ± R salvage therapy.
DRUG	Gemcitabine	Administered by IV infusion, as part of the GDP ± R salvage therapy.

Timeline

• Start date: 2024-02-15
• Primary completion: 2027-05-14
• Completion: 2027-05-14
• First posted: 2024-01-30
• Last updated: 2026-04-08

Locations

101 sites across 16 countries: Argentina, Australia, Brazil, Chile, Colombia, Hungary, Italy, Malaysia, Netherlands, Romania, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study