Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-19-031
Prinicipal Investigator
Naik, Seema
Phase
Phase II
Age Group
Adult
Scope
National
Secondary Protocol No.
PrE0405
Title
Phase II Study of Bendamustine and Rituximab plus Venetoclax in Untreated Mantle Cell Lymphoma over 60 Years of Age
Objective
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.
Applicable Disease Sites
Non-Hodgkin's Lymphoma
Status
Open
Participating Institutions
Hershey Medical Center