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

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

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.

Sponsors & Collaborators

• Regeneron Pharmaceuticals

  lead INDUSTRY

Principal Investigators

• Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-15

Primary Completion

2028-05-29

Completion

2029-05-29

FDA Drug

Yes

Countries

• Argentina
• Australia
• Brazil
• Chile
• Colombia
• Hungary
• Malaysia
• Romania
• Singapore
• South Korea
• Spain
• Taiwan
• Thailand
• Turkey (Türkiye)

Study Locations