A Randomized 3-Arm Phase II Study Comparing 1.) Bendamustine Rituximab and High Dose Cytarabine (BR/CR) 2.) Bendamustine Rituximab High Dose Cytarabine and Acalabrutinib (BR/CR-A) and 3.) Bendamustine Rituximab and Acalabrutinib (BR-A) in Patients = 70 years old with Untreated Mantle Cell Lymphoma

Brief description of study

The purpose of the study is to determine the efficacy and tolerability of bendamustine (B), rituximab (R) and high dose cytarabine (C) [(BR/CR] versus BR/CR plus acalabrutinib (A) [BR/CR-A], versus bendamustine, rituximab, and acalabrutinib (BR-A). We want to know which combination of cancer drugs most effectively treats patients with Mantle Cell Lymphoma (MCL) that have never been treated. We are doing this study, so that we can find out if one of these drug combinations is better or worse than the usual approach. Acalabrutinib is an investigational for treating newly diagnosed MCL. It is Food and Drug Administration (FDA) approved for MCL that has not responded to treatment or relapsed.


Clinical Study Identifier: s20-01874
ClinicalTrials.gov Identifier: NCT04115631
Principal Investigator: Catherine M Diefenbach.


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