42
Participants
Start Date
November 12, 2018
Primary Completion Date
February 28, 2026
Study Completion Date
December 31, 2026
Bendamustine
Subjects will receive Bendamustine 50-90 mg/m2 on days 1-2 for three cycles with each cycle being 28 days.
Venetoclax
"Venetoclax: 12 cycles~Venetoclax will then be started after 3 cycles of BR. Dosing for venetoclax will be in a step wise fashion as follows:~* Cycle 4 days 1-7 (Week 1): 20 mg once daily~* Cycle 4 days 8-14 (Week 2): 50 mg once daily~* Cycle 4 days 15-21 (Week 3): 100 mg once daily~* Cycle 4 days 22-28 (Week 4): 200 mg once daily~* Cycle 4 day 29 and thereafter (Week 5 and on): 400 mg once daily; continue until disease progression, unacceptable toxicity, or 12 cycles duration."
Rituximab
For cycles 1 through 3, subjects will receive BR on days 1 and 2. For cycles 5-10, subjects will receive rituximab monotherapy at 375 mg/m2 (cycle 5) or rituximab at 500 mg/m2 (cycles 6-10) on day 1 (or days 1 and 2 if split-dose).
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital, New York
Nicole Lamanna
OTHER