A PHASE III MULTICENTER RANDOMIZED OPEN-LABEL STUDY COMPARING THE EFFICACY AND SAFETY OF GLOFITAMAB (RO7082859) IN COMBINATION WITH POLATUZUMAB VEDOTIN PLUS RITUXIMAB CYCLOPHOSPHAMIDE DOXORUBICIN AND PREDNISONE (POLA-R-CHP) VERSUS POLA-R-CHP IN PREVIOUSLY UNTREATED PATIENTS WITH LARGE B-CELL LYMPHOMA

Brief description of study

This study is to see which treatment (glofitamab in combination with Pola-R-CHP or Pola-R-CHP alone) works better for a large B-Cell Lymphoma. It involves patients who haven't had treatment before for their type of cancer. They'll be split into two groups, and each group will get a different treatment. Doctors will look at things like how sick patients are and where they live to make sure the groups are fair. The treatment will start within a week of being chosen. One group will get one treatment for the first six rounds, then a different one for the next two rounds. The other group will get the same treatment for all eight rounds. Doctors will keep a close eye on any side effects and how well the treatment works. They'll use special tests to check. Another group of experts will also check the results to make sure they're accurate. If someone doesn't pass the first check, they might get another chance.


Clinical Study Identifier: s23-00439
ClinicalTrials.gov Identifier: NCT06047080
Principal Investigator: Catherine M Diefenbach.
Other Investigators: Vathveal Mathews, John Leslie Vaughn, David Kaminetzky, Kathryn Dowling, Victoria Hohmann, Kenneth B Hymes, Tamia Davis, Oscar B Lahoud, Danny Perlaza, Cosmin Adrian Tegla, Amy L Sun, Caitlin Elizabeth Ryan, Maxim Kreditor, Meina Fung, Tibor Moskovits, Ellaine R Yap, Thaleshravi Prashad, Michael L. Grossbard, Marc Justin Braunstein, Ariel Karwat, Bonnie Kiner-Strachan, Michael E Garrison, Bruce G Raphael.


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