PhIII Odronextamab Comb w/CHOP vs Rituximab Comb w/CHOP in Prev Untrx Pts w/Diffuse Large Bcell Lymp

UCI Specialty Area: Cancer

Principal Investigator: Elizabeth A Brem

Official Title: A Phase III, Open label, Randomized Study Comparing the Efficacy and Safety of Odronextamab (REGN 1979), an Anti-CD20 × Anti-CD3 Bispecific Antibody, in Combination with CHOP (O-CHOP) versus Rituximab in Combination with CHOP (R-CHOP) in Previously Untreated Participants with Diffuse Large B-cell Lymphoma (DLBCL) (OLYMPIA-3)

A Study On:

Non-Hodgkin's Lymphoma

Study Description

This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy. The study is focused on patients with diffuse large B-cell lymphoma (DLBCL) that have not been treated before (called "previously untreated"), have come back after treatment (called "relapsed"), or have not responded to treatment (called "refractory").

This study will be made up of Part 1a, Part 1b, and Part 2.The aim of Part 1a and Part 1b of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy in Part 2 of the study.

The aim of Part 2 of the study is to see how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab and chemotherapy, the current standard of care treatment approved for Non-Hodgkin's lymphoma (NHL). Standard of care means the usual medication expected and used when receiving treatment for a condition.

Eligibility

If you have Previously Untreated Diffuse Large B-cell Lymphoma

If you are at least 18 years old.

You cannot participate in this study if you are female who is pregnant or breastfeeding or planning to become pregnant.

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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