Study on Copanlisib and Venetoclax for Treating Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Sponsor: Dana-Farber Cancer Institute
ClinicalTrials ID:NCT04572763
This clinical trial is exploring the combination of two drugs, copanlisib and venetoclax, to see if they can effectively treat patients with diffuse large B-cell lymphoma (DLBCL) that has returned or not responded to previous treatments.
Patient Parameters
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Program Overview
The purpose of this study is to test the safety and effectiveness of combining two drugs, copanlisib and venetoclax, for treating patients with diffuse large B-cell lymphoma (DLBCL) that has either come back or not responded to other treatments. Copanlisib is given through an IV and is approved for treating a different type of lymphoma, while venetoclax is an oral medication approved for certain types of leukemia and lymphoma. This study will determine if these drugs can work together to treat DLBCL.
Description
This study is divided into two phases. In Phase I, researchers will determine the safest dose of venetoclax to use with copanlisib and observe any side effects. In Phase II, they will evaluate how well this drug combination works in shrinking or controlling DLBCL tumors. The study will also look at genetic changes in the cancer to see if certain mutations make the treatment more effective. Approximately 48 people will participate in this study. The pharmaceutical companies Bayer and Abbvie are supporting this research by providing the study drugs and funding.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL).
- Cancer must have returned after or not responded to previous treatments like stem cell transplant or CAR T-cell therapy.
- Willing to have a biopsy before starting treatment.
- Must be in good general health with an ECOG performance status of less than 2.
- Must be 18 years or older.
- Must meet specific blood count and organ function criteria.
- Women of childbearing potential and men must agree to use effective birth control during the study and for a period after the last treatment.
- Must be able to understand and sign a consent form.
Exclusion Criteria
- Have received cancer treatment within 2 weeks before starting the study, with some exceptions.
- Have a history of other cancers, unless treated and inactive for at least 2 years.
- Have had a stem cell transplant recently or have active graft vs. host disease.
- Have received live vaccines within 4 weeks before starting the study.
- Have an active autoimmune disease requiring treatment.
- Have a recent or uncontrolled infection.
- Have bleeding disorders or recent stroke.
- Have HIV, hepatitis B, or hepatitis C infections.
- Have had major surgery recently.
- Have serious medical conditions that could affect safety.
- Have uncontrolled heart conditions or recent heart issues.
- Have digestive issues affecting medication absorption.
- Are pregnant or breastfeeding.
- Are taking other cancer study drugs or certain medications that interact with the study drugs.
- Have uncontrolled high blood pressure or diabetes.
- Have allergies to the study drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Cancer Center | 91010 | Duarte | California |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Siteman Cancer Center at Washington University | 63110 | St Louis | Missouri |
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