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
Recruiting now · Phase 3
Conditions studied: Diffuse Large B-cell Lymphoma (DLBCL)
In brief
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 study drug on quality of life and ability to complete routine daily activities
Key facts
- Study ID
- NCT06091865
- Run by
- Regeneron Pharmaceuticals
- People needed
- 904
- Starts
- 2023-12-13
- Expected to finish
- 2029-09-12
- Last updated by the study team
- 2026-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Pindara Private Hospital — Benowa, Queensland, Australia (enrolling)
- University of California Irvine Medical Center — Orange, California, United States (enrolling)
- David Geffen School of Medicine at UCLA — Los Angeles, California, United States (enrolling)
- Icon Cancer Centre - Wesley — Auchenflower, Queensland, Australia (enrolling)
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States (enrolling)
- St Vincent Ascension at Peyton Manning Childrens Hospital — Indianapolis, Indiana, United States (enrolling)
- University of California (UC) Davis — Sacramento, California, United States (enrolling)
- University of Kentucky — Lexington, Kentucky, United States (enrolling)
- Mayo Clinic Jacksonville — Jacksonville, Florida, United States (enrolling)
- Mayo Clinic - Arizona — Scottsdale, Arizona, United States (enrolling)
- Henry Ford Health System — Detroit, Michigan, United States (enrolling)
- Cancer and Hematology Centers of Western Michigan — Grand Rapids, Michigan, United States (enrolling)
- Mayo Clinic - Rochester — Rochester, Minnesota, United States (enrolling)
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (enrolling)
- Stony Brook University Hospital — Stony Brook, New York, United States (enrolling)
- Investigative Clinical Research of Indiana — Noblesville, Indiana, United States (enrolling)
- Duke University Medical Center — Durham, North Carolina, United States (enrolling)
- East Carolina University — Greenville, North Carolina, United States (enrolling)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
- University of Maryland Greenebaum Comprehensive Cancer Center — Baltimore, Maryland, United States (enrolling)
- Community Cancer Trials of Utah — Ogden, Utah, United States (enrolling)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
- Liverpool Hospital — Liverpool, New South Wales, Australia (enrolling)
- Calvary Mater Newcastle — Waratah, New South Wales, Australia (enrolling)
- Epworth Freemasons — East Melbourne, Victoria, Australia (enrolling)
Full record on ClinicalTrials.gov
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