Ibrutinib + Chemotherapy for CNS Lymphoma
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial requires that you stop taking certain medications before starting the study drug. Specifically, you must stop using warfarin or similar anticoagulants at least seven days prior, and any drugs that affect the P450/CYP3A enzyme at least two weeks prior. Additionally, you must stop systemic immunosuppressant therapy at least 28 days before the first dose.
What data supports the effectiveness of the drug Ibrutinib in treating CNS Lymphoma?
Research shows that Ibrutinib, when used alone or with chemotherapy, can significantly reduce tumors in patients with central nervous system lymphoma. In one study, 94% of patients showed tumor reductions with Ibrutinib alone, and 86% achieved complete remission when combined with chemotherapy.12345
Is the combination of Ibrutinib and chemotherapy safe for treating CNS lymphoma?
Ibrutinib, when used alone or with chemotherapy for CNS lymphoma, has shown some safety concerns, particularly an increased risk of aspergillosis (a type of fungal infection) due to its effect on the immune system. However, it has been generally well-tolerated in some patients, with one case showing good tolerance and sustained remission.12367
How does the drug ibrutinib differ from other treatments for CNS lymphoma?
Ibrutinib is unique because it is a Bruton's tyrosine kinase inhibitor, which means it works by blocking a specific protein that helps cancer cells grow. This mechanism is different from standard chemotherapy, which often cannot cross the blood-brain barrier to reach the central nervous system effectively.89101112
What is the purpose of this trial?
The purpose of this study is to test any good or bad effects of the study drug called of ibrutinib (also known as Imbruvica™). At this stage of this trial, the study is investigating whether Ibrutinib can be incorporated into the established first-line chemotherapy regimen rituximab, methotrexate, vincristine, and procarbazine (R-VMP) in order to further refine the first-line induction therapy for PCNSL, as observed by a superior CRR (complete response rate) (ARM D RECRUITING ONLY)
Research Team
Christian Grommes, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Eligibility Criteria
This trial is for adults with primary or secondary central nervous system lymphoma who have had at least one prior CNS therapy (except for some newly diagnosed cases). They must understand the study and consent, have a certain level of physical function, adequate organ function, agree to use effective birth control, and not be pregnant. Exclusions include uncontrolled infections, certain drug interactions, severe heart conditions, inability to swallow capsules, among others.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 4 cycles of therapy with Methotrexate, Rituximab, Vincristine, Procarbazine, and Ibrutinib. Ibrutinib is dosed at 560 mg daily, with a safety lead-in of 6 patients.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with progression-free survival assessed.
Dose Escalation
Establish the maximum-tolerated dose (MTD) of ibrutinib as a single agent and in combination with high-dose Methotrexate (HD-MTX).
Treatment Details
Interventions
- Ibrutinib
Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:
- Chronic lymphocytic leukemia
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
- Graft-versus-host disease
- Chronic lymphocytic leukemia/small lymphocytic lymphoma
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
- Graft-versus-host disease
- Chronic lymphocytic leukemia
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
- Chronic lymphocytic leukemia
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Pharmacyclics LLC.
Industry Sponsor
Dr. Maky Zanganeh
Pharmacyclics LLC.
Chief Executive Officer
Degree from Louis Pasteur University in Strasbourg, France; MBA from Schiller International University in France
Dr. Ellie Im
Pharmacyclics LLC.
Chief Medical Officer
MD from an unspecified institution
Janssen Biotech, Inc.
Industry Sponsor