13
Participants
Start Date
November 29, 2018
Primary Completion Date
February 9, 2020
Study Completion Date
April 14, 2025
Bendamustine
Bendamustine will be administered at a dose of 90 mg/m\^2 IV over 30 minutes on Days 1 and 2 of Cycles 1-3
Rituximab
In Cycle 1, rituximab will be administered at a dose of 375 mg/m\^2 IV on Day 1 or 2 at the investigator's discretion in order to reduce the risk of a first infusion reaction. Rituximab will be given on Day 1 of Cycles 1 through 6.
Acalabrutinib
The capsules should be swallowed intact with water and with or without food.
Cytarabine
On Days 1 and 2 of Cycles 4-6, following rituximab dosing, cytarabine will be administered IV every 12 hours for a total of 4 doses.
Leukapheresis
Until collection of ≥ 2 x 106 CD34+ stem cells / kg
Peripheral blood
-Baseline, end of Cycle 3, 4-6 weeks after Cycle 6 Day 1, and if the patient discontinues protocol therapy prior to completion of Cycle 6
Oral rinse
-Baseline
Bone marrow collection
-Bone marrow will be collected at baseline if the patient requires a marrow for staging purposes and at end of treatment if the patient requires a marrow for restaging.
Washington University School of Medicine, St Louis
Collaborators (1)
Acerta Pharma BV
INDUSTRY
Washington University School of Medicine
OTHER