NCT04572763

Copanlisib Plus Venetoclax in R/R DLBCL

A Phase I/II Study of Copanlisib Plus Venetoclax for the Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is evaluating the combination of two drugs, copanlisib and venetoclax, as a possible treatment for trelapsed/refractory diffuse large B-cell lymphoma (DLBCL) The names of the study drugs involved in this study are: * Copanlisib * Venetoclax

Detailed description

This study is an open-label, multi-center, non-randomized phase I/II study of the combination treatment copanlisib + venetoclax in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). Phase I clinical trials test the safety of investigational drugs, and also try to define the appropriate dose of the investigational drugs to use for further studies. Phase II clinical trials test the safety and effectiveness of investigational drugs to learn whether the drugs work in treating a specific disease."Investigational" means that the drugs are being studied. Copanlisib is an IV medication that is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior therapies. Venetoclax is an oral medication that is approved by the U.S. FDA for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and certain patients with acute myeloid leukemia (AML). The FDA has not approved copablisib or venetoclax for the treatment of DLBCL or the combination of copanlisib and venetoclax as a treatment for any disease. In the phase I portion of this study, the investigators are looking to determine the dose of venetoclax that is safe to give with copanlisib and to see what the side effects are of this combination. In the phase II trial, the investigators will be determining how effective venetoclax and copanlisib are for the treatment of R/R DLBCL. Data from laboratory suggest that some subsets of DLBCL are enriched for mutations that make them sensitive to the combination of copanlisib plus venetoclax. This study will look at genetic changes in your cancer and determine if abnormalities in specific genes make these drugs more or less effective. It is expected that about 48 people will take part in this research study. Bayer, a pharmaceutical company, is supporting this research study by providing the study drug copanlisib and funding for this study. Abbvie, a pharmaceutical company, is supporting this research study by providing the study drug venetoclax and funding for this study.

Conditions

• Diffuse Large B Cell Lymphoma
• Relapsed Diffuse Large B-Cell Lymphoma
• Refractory Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Copanlisib	Intravenous infusion
DRUG	Venetoclax	Tablet taken orally

Timeline

• Start date: 2021-09-08
• Primary completion: 2025-07-29
• Completion: 2026-07-29
• First posted: 2020-10-01
• Last updated: 2026-01-07

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study