Phase II Study of Bendamustine and Rituximab plus Venetoclax in Untreated Mantle Cell Lymphoma over 60 Years of Age
Primary Objective To determine the CR rate of BR + venetoclax in untreated MCL patients over the age of 60 years. Secondary Objectives Evaluate the safety of the combination, with particular attention to TLS incidence with Cycle 1. To determine the overall response rate (complete response [CR] + partial response [PR]) of BR + venetoclax in untreated MCL patients over the age of 60 years. To determine the survival (progression-free survival [PFS] and overall survival [OS]) of MCL patients treated with BR + venetoclax induction. Exploratory Objectives Bone marrow aspirate and peripheral blood assessed minimal residual disease (MRD) negative rate of BR + venetoclax in untreated MCL patients over the age of 60 years. Evaluate the utility of morphologic assessment of bone marrow biopsy and aspiration when combined with peripheral blood MRD and PET assessments on CR rate at end of treatment.