PhIII Odronextamab (REGN1979) vs Investigator's Choice in Prev Untrx Pts w/ Follicular Lymphoma

UCI Specialty Area: Cancer

Principal Investigator: Elizabeth A Brem

Official Title: A Phase III, Open-Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, Versus Investigator's Choice in Previously Untreated Participants with Follicular Lymphoma (OLYMPIA-1)

A Study On:

Non-Hodgkin's Lymphoma

Study Description

This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma or NHL).

This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is. The aim of Part 2 of the study is to see how the study drug works compared to rituximab and chemotherapy (the current standard of care for NHL). Standard of care means the usual medication expected and used when receiving treatment for a condition.

The study is looking at several other research questions, including:

What side effects may happen from taking the study drug

How much study drug is in your blood at different times

Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

The impact from the study drug on your quality of life and ability to complete routine daily activities.

Eligibility

If you have Previously Untreated Follicular 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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You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health

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Future Research Use
Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information

Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.

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