NCT04155840

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

MRD-Guided Abbreviation of Bendamustine and Rituximab Chemotherapy in Combination With Copanlisib in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a dose de-escalation study of copanlisib. Patients receive copanlisib intravenously (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. After completion of study treatment, patients are followed up at 14 days, then periodically for up to 3 years.

Conditions

• Lymphoid Leukemia
• Non-Hodgkin's Lymphoma
• Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
DRUG	Copanlisib	Given IV
BIOLOGICAL	Rituximab	Given IV
DRUG	Bendamustine	Given IV

Timeline

• Start date: 2020-01-31
• Primary completion: 2021-03-16
• Completion: 2021-03-16
• First posted: 2019-11-07
• Last updated: 2022-04-11
• Results posted: 2022-04-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study