About this trial
This study is looking at how well an experimental drug called odronextamab works when combined with chemotherapy for patients with Diffuse Large B-cell Lymphoma (DLBCL) who have not been treated before. The goal is to see if this combination is better and safer than the standard treatment using rituximab and chemotherapy. This trial also explores the side effects of the study drug and how it affects patients' daily lives.
This is a Phase 3 trial, which means it is looking at how well the treatments work and how safe they are. The trial is FDA-regulated and aims to include about 904 participants.
Who can join
Adults aged 18 and older can join the study if they have untreated DLBCL or DLBCL that has come back after treatment. They should have measurable disease and meet certain health criteria. Some conditions may prevent participation, like having certain infections or other cancers. The trial team will confirm who is eligible to join.
Condition
Diffuse Large B-cell Lymphoma (DLBCL)
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants will be randomly placed into one of two groups. One group will receive the new drug odronextamab along with standard chemotherapy (called Odro-CHOP). The other group will receive rituximab with chemotherapy (called R-CHOP). Everyone will get treatment, but the specific group they are in will be decided by chance.
Where
This trial is running at 20 locations in the United States. 17 of them are currently recruiting.
Beth Israel Deaconess Medical Center
Boston, Massachusetts
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan
Community Cancer Trials of Utah
Ogden, Utah
David Geffen School of Medicine at UCLA
Los Angeles, California
Duke University Medical Center
Durham, North Carolina
East Carolina University
Greenville, North Carolina
Henry Ford Health System
Detroit, Michigan
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana
The first 8 of 20 sites are listed here. The registry record has the full list.