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

The purpose of the study is to evaluate the study drug CC-486 (oral azacitidine) plus the standard drug therapy that fights cancer cells for patients who are 75 years of age or older who were recently diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL). We want to compare this combination (study drug CC-486 and standard drug therapy) and standard drug therapy alone, for assessing side effects, disease progression, life expectancy. We are doing this study because we want to find out if this approach is better or worse than the usual approach for the DLBCL. The study drug CC-486 (oral azacitidine) is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.


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


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