RecruitingPhase 2NCT05998642

Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma

A Phase 2 Study of Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary Central Nervous System Lymphoma


Sponsor

Canadian Cancer Trials Group

Enrollment

30 participants

Start Date

Feb 13, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is being done to answer the following question: Can the addition of a new drug to the usual treatment lower the chance of primary central nervous system lymphoma growing or spreading? This study is being done to find out if this approach is better or worse than the usual approach for this type of cancer. The usual approach is defined as the care most people get for Primary Central Nervous System Lymphoma (PCNSL).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of drugs — ibrutinib, rituximab, and high-dose methotrexate — in patients with a rare type of lymphoma that starts in the brain or spinal cord (called primary CNS lymphoma), who are not able to undergo stem cell transplantation. **You may be eligible if...** - You have been diagnosed with primary CNS lymphoma (a lymphoma in your brain or spinal cord), confirmed by biopsy or fluid sample - You are 18 years or older - You are not eligible for high-dose chemotherapy and stem cell transplant — either because you are 65 or older or because of other health conditions - Your doctor considers you healthy enough to receive this treatment combination **You may NOT be eligible if...** - You are able to and would be considered for a stem cell transplant - You have not been diagnosed with CNS lymphoma Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMethotrexate

3.5mg/m2 IV

DRUGRituximab (where available)

375mg/m2 / 1400mg IV or SC

DRUGIbrutinib

Dose and schedule assigned at enrollment


Locations(8)

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

BCCA - Vancouver

Vancouver, British Columbia, Canada

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, Canada

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

The Research Institute of the McGill University

Montreal, Quebec, Canada

CHU de Quebec-Hopital l'Enfant-Jesus (HEJ)

Québec, Quebec, Canada

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05998642


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