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Study identifier: NCT06091865 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma

Condition: Diffuse Large B-cell Lymphoma (DLBCL)  ·  Sponsor: Regeneron Pharmaceuticals

PhasePhase 3
Planned participants904
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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"). Patients with DLBCL that have come back after treatment (called "relapsed"), or have not responded to treatment (called "refractory"), can also participate in this study. 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 (the comparator drug), and chemotherapy, the current standard of care treatment approved for DLBCL. 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 when combined with chemotherapy * 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) * The impact from the stud…

This description comes directly from the study's public registry record.

Talk to the study team

Clinical Trials Administrator  ·  844-734-6643  ·  clinicaltrials@regeneron.com

Always discuss trial participation with your own doctor first.

Locations (168)

Mayo Clinic - ArizonaScottsdale, Arizona, United StatesRecruiting
David Geffen School of Medicine at UCLALos Angeles, California, United StatesRecruiting
University of California Irvine Medical CenterOrange, California, United StatesRecruiting
University of California (UC) DavisSacramento, California, United StatesRecruiting
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolis, Indiana, United StatesRecruiting
St Vincent Ascension at Peyton Manning Childrens HospitalIndianapolis, Indiana, United StatesRecruiting
Investigative Clinical Research of IndianaNoblesville, Indiana, United StatesRecruiting
University of KentuckyLexington, Kentucky, United StatesRecruiting
University of Maryland Greenebaum Comprehensive Cancer CenterBaltimore, Maryland, United StatesRecruiting
Beth Israel Deaconess Medical CenterBoston, Massachusetts, United StatesRecruiting
Henry Ford Health SystemDetroit, Michigan, United StatesRecruiting
Cancer and Hematology Centers of Western MichiganGrand Rapids, Michigan, United StatesRecruiting

+ 156 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06091865