A Phase II/III randomized study of R-miniCHOP with or without oral azacitidine (CC-486) in participants age 75 years or older with newly diagnosed diffuse large B cell lymphoma Grade IIIb Follicular Lymphoma transformed lymphoma and high-grade B-cell lymphomas with MYC and BCL2 and/or BCL6 rearrangements

Brief description of study

This trial is a Phase II/III evaluation of CC-486 (oral azacitidine) added to R-mini-CHOP. The primary endpoint of the Phase II component is 1-year PFS and will determine study continuation to the Phase III component. The primary endpoint of the Phase III components is 2-year OS. Prior to the full Phase II portion of the study, 40 evaluable patients (estimated that 44 patients will be registered to achieve 40 evaluable patients) will be included in a 1:1 randomized safety run-in.


Clinical Study Identifier: s21-01259
ClinicalTrials.gov Identifier: NCT04799275
Principal Investigator: Catherine M Diefenbach.
Other Investigators: Maxim Kreditor, Marc Justin Braunstein, Jaime Andres Suarez Londono, Vathveal Mathews, Michael L. Grossbard, Bonnie Kiner-Strachan, Bruce G Raphael, Kenneth B Hymes, Jingmei Hsu, Ellaine R Yap, John Leslie Vaughn, Elizabeth A Raetz, Shella Saint Fleur-Lominy, David Kaminetzky, Kathryn Dowling, Michael E Garrison, Tibor Moskovits, Elizabeth Ann Roman, Thaleshravi Prashad.


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