Copanlisib + Venetoclax for Mantle Cell Lymphoma
Trial Summary
What is the purpose of this trial?
This phase I/II trial studies the side effects, best dose, and effectiveness of copanlisib and venetoclax in treating patients with mantle cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Copanlisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving copanlisib and venetoclax may help treat patients with mantle cell lymphoma.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot take medications or foods that strongly affect CYP3A4 within 7 days of starting the study treatment, and you cannot be on high-dose corticosteroids.
What data supports the effectiveness of the drug combination Copanlisib and Venetoclax for treating Mantle Cell Lymphoma?
Venetoclax has shown effectiveness in treating Mantle Cell Lymphoma (MCL) when combined with other drugs, achieving high response rates and minimal residual disease clearance in patients. Additionally, Venetoclax has been effective in treating other types of blood cancers, such as chronic lymphocytic leukemia, with good response rates and safety profiles.12345
Is the combination of Copanlisib and Venetoclax safe for treating Mantle Cell Lymphoma?
Venetoclax has been generally well tolerated in patients with various types of non-Hodgkin lymphoma, including mantle cell lymphoma, with most side effects being mild to moderate. Common serious side effects include low blood cell counts, which can be managed with supportive care and dose adjustments.13467
What makes the drug combination of Copanlisib and Venetoclax unique for treating Mantle Cell Lymphoma?
The combination of Copanlisib and Venetoclax is unique because it targets specific proteins involved in cancer cell survival, potentially offering a new approach for treating Mantle Cell Lymphoma, a condition with limited standard treatment options. Venetoclax is known for its ability to inhibit BCL-2, a protein that helps cancer cells survive, while Copanlisib targets different pathways, which may enhance the overall effectiveness of the treatment.12468
Research Team
Alexey Danilov
Principal Investigator
City of Hope Medical Cneter
Eligibility Criteria
This trial is for adults with mantle cell lymphoma that has returned or isn't responding to treatment. Participants must be able to take pills, have a life expectancy of at least 3 months, and proper organ function. They should not have HIV, hepatitis B or C, uncontrolled diseases like diabetes or heart conditions, and women must not be pregnant.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive copanlisib intravenously on days 1, 8, and 15, and venetoclax orally daily on days 1-28. Treatment repeats every 28 days for up to 26 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion every 3 months for 2 years.
Treatment Details
Interventions
- Copanlisib Hydrochloride
- Venetoclax
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator