Bendamustine and Rituximab in Combination With Copanlisib for the Treatment of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT04155840
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Copanlisib — DRUG
    Given IV
  • Rituximab — BIOLOGICAL
    Given IV
  • Bendamustine — DRUG
    Given IV

Study Details

This trial studies how well bendamustine and rituximab in combination with copanlisib work in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. Drugs used in chemotherapy, such as bendamustine and rituximab, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Copanlisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bendamustine and rituximab with copanlisib may work better than bendamustine and rituximab alone in treating chronic lymphocytic leukemia or small lymphocytic lymphoma.

Key Dates

Start date
Jan 31, 2020
Status verified
Apr 2022
Primary completion
Mar 16, 2021
Completion
Mar 16, 2021

Study Design

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

Arms

  • Experimental: Treatment (copanlisib, rituximab, bendamustine)
    Patients receive copanlisib IV over 1 hour on days 1, 8 and 15 or days 1 and 15 (depending on dose level). Patients also receive rituximab IV on day 1 and bendamustine IV on days 1 and 2 of cycles 1-4. Patients who achieve at least a partial response (MRD-positive) continue on treatment for 2 additional cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 7, patients receive copanlisib IV over 1 hour on days 1 and 15 for an additional 6 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Estimate the Marrow Minimal Residual Disease (MRD)-Negative Rate [ Time Frame: End of cycle 4 (each cycle is 28 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109-

Find similar trials in Seattle, WA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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