NCT05998642

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

If a patient decides to take part in this study, the patient will get 3 months of treatment with methotrexate and ibrutinib as well as rituximab (if rituximab is given for PCNSL in the applicable province). This will be followed by treatment with ibrutinib alone for up to 2 years of total treatment time. After finishing study treatment, and even if patients stop treatment early, the study doctor will continue to follow the patient's condition for the rest of their life or until all study results are known (in approximately 6 years), watch for side effects and keep track of the patient's health. If there are any side effects that may be related to ibrutinib, the patient will be asked to come back to the clinic every 3 months until side effects improve. If there are no side effects from ibrutinib the patient will be asked to come back to clinic every 6 months until cancer worsens, and then every 6 months may be contacted by phone.

Conditions

• Non-hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Methotrexate	3.5mg/m2 IV
DRUG	Rituximab (where available)	375mg/m2 / 1400mg IV or SC
DRUG	Ibrutinib	Dose and schedule assigned at enrollment

Timeline

• Start date: 2024-02-13
• Primary completion: 2028-05-31
• Completion: 2028-12-31
• First posted: 2023-08-21
• Last updated: 2026-04-14

Locations

8 sites across 1 country: Canada