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

Part of paid clinical trials in New York, New York.

Sponsor
Nicole Lamanna
Study ID
NCT03609593
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

The purpose of this study is to determine the efficacy of bendamustine and rituximab (BR) followed by venetoclax for 12 months. The total time on therapy is 15 months. Bendamustine and rituximab is a commonly used treatment for CLL. Venetoclax is an oral drug that blocks a protein called BCL-2 which is present on CLL cells. It is approved for patients with relapsed (the cancer has come back) or refractory (the cancer did not respond) CLL who harbor a deletion in the short arm of chromosome 17 \[del(17p)\]. When this drug is used by itself, many patients needed to be admitted to the hospital to monitor for a complication known as tumor lysis syndrome. This is an oncologic emergency that is caused by massive destruction of tumor cells with the release of large amounts of electrolytes and other molecules into the blood that can lead to renal failure and potentially death.

Key Dates

Start date
Nov 12, 2018
Status verified
Feb 2026
Primary completion
Jan 27, 2026
Completion
Jan 27, 2026

Study Design

Enrollment
42 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BR followed by venetoclax and rituximab
    Subjects will be on Bendamustine 50-90 mg/m2 on days 1-2 for three cycles with each cycle being 28 days, and Rituximab 375 mg/m2 on day 1 or days 1-2 for three cycles with each cycle being 28 days. Venetoclax will then be started in a step-wise fashion per the package insert.

Primary Outcome Measure

Overall response rate (ORR) after the completion of all therapy [ Time Frame: 15 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical Center / NewYork-Presbyterian HospitalNew YorkNew York10032-

Find similar trials in New York, NY

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital· New York, NY

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