Copanlisib + Ibrutinib for Central Nervous System Lymphoma
Trial Summary
Do I need to stop my current medications to join the trial?
Yes, you may need to stop certain medications before joining the trial. Specifically, you must stop using warfarin or other vitamin K antagonists 7 days before starting the trial drug, and strong CYP3A4/5 inhibitors and inducers 2 weeks prior. Additionally, enzyme-inducing antiepileptic drugs should be switched to non-inducing alternatives 2 weeks before starting the trial.
What data supports the effectiveness of the drugs Copanlisib and Ibrutinib for treating central nervous system lymphoma?
Research shows that Ibrutinib, a drug that can cross the blood-brain barrier, has been effective in treating central nervous system lymphomas, with studies reporting good response rates and improved survival compared to traditional chemotherapy. Additionally, Ibrutinib has shown promise in maintaining remission in patients with primary central nervous system lymphoma.12345
What safety data exists for Ibrutinib in treating central nervous system lymphoma?
Ibrutinib, used alone or with other treatments, has shown good tolerance in patients with central nervous system lymphoma, but there is a risk of increased aspergillosis (a fungal infection) due to its effect on the immune system. It has been used successfully in elderly patients and those with relapsed conditions, with some experiencing rapid symptom recovery and sustained remission.14678
How is the drug combination of Copanlisib and Ibrutinib unique for treating central nervous system lymphoma?
The combination of Copanlisib and Ibrutinib is unique because Ibrutinib is a Bruton's tyrosine kinase inhibitor that can cross the blood-brain barrier, offering a targeted approach for central nervous system lymphoma, which is a rare and aggressive cancer with limited standard treatment options. This combination may provide a novel therapeutic strategy, especially for patients who are not suitable for traditional chemotherapy.12349
What is the purpose of this trial?
This trial is testing the safety of using two drugs, copanlisib and ibrutinib, together. The study focuses on patients with a type of brain and spinal cord cancer called PCNSL. These drugs work by blocking proteins that cancer cells need to grow.
Research Team
Christian Grommes, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Eligibility Criteria
Adults with primary central nervous system lymphoma (PCNSL) that's come back or hasn't responded to treatment, or those newly diagnosed but can't have standard chemo. They must be able to handle MRI/CT scans and lumbar punctures, have a life expectancy over 3 months, and good organ function. Contraception is required during the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Phase Ib
Participants receive Ibrutinib and Copanlisib to determine the maximum tolerated dose using a '3+3' design
Treatment Phase II
Participants receive sequential drug dosing with Ibrutinib and Copanlisib in 28-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Copanlisib
- Ibrutinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor