M20-638: A PHASE 3 MULTICENTER RANDOMIZED OPEN-LABEL TRIAL OF EPCORITAMAB IN COMBINATION WITH RITUXIMAB AND LENALIDOMIDE (R2) COMPARED TO RITUXIMAB AND LENALIDOMIDE (R2) ALONE IN SUBJECTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA

Brief description of study

This is a trial testing a new medicine called epcoritamab, when used with other medicines called rituximab and lenalidomide (together called "R2"), to see if it has few side effects and works well for patients with follicular lymphoma who have already tried other treatments (one anti-CD20 containing treatment) before. The study will have three groups of patients who will get different treatments. Everyone will be watched closely, and they will have special scans at different times in the study to see how they're doing. The doctors will look at the results after a certain number of patients have good or bad outcomes. There will be a secondary group of experts who will make sure everything is safe during the trial. The study team will take blood samples to learn more about the treatment and hope to see results that the medicine has helped patients.


Clinical Study Identifier: s21-00197
ClinicalTrials.gov Identifier: NCT05409066
Principal Investigator: Catherine M Diefenbach.
Other Investigators: Kenneth B Hymes, Marc Justin Braunstein, Maxim Kreditor, Bonnie Kiner-Strachan, Michael L. Grossbard, John Leslie Vaughn, Bruce G Raphael, Shella Saint Fleur-Lominy, David Kaminetzky, Tibor Moskovits, Ellaine R Yap, Thaleshravi Prashad.


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