Bendamustine/rituximab Followed by Venetoclax and Rituximab for Treatment of Chronic Lymphocytic Leukemia

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

November 12, 2018

Primary Completion Date

February 28, 2026

Study Completion Date

December 31, 2026

Conditions
Chronic Lymphocytic Leukemia
Interventions
DRUG

Bendamustine

Subjects will receive Bendamustine 50-90 mg/m2 on days 1-2 for three cycles with each cycle being 28 days.

DRUG

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."

DRUG

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).

Trial Locations (1)

10032

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital, New York

All Listed Sponsors
lead

Nicole Lamanna

OTHER

NCT03609593 - Bendamustine/rituximab Followed by Venetoclax and Rituximab for Treatment of Chronic Lymphocytic Leukemia | Biotech Hunter | Biotech Hunter