RecruitingPhase 3NCT07104032

IGNITE: Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)

A Phase 3, Multi-regional, Open-label, Randomized Study of Tirabrutinib vs Rituximab and Temozolomide in Participants With Relapsed/Refractory Primary Central Nervous System Lymphoma


Sponsor

Ono Pharmaceutical Co., Ltd.

Enrollment

132 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this clinical trial is to evaluate efficacy and safety of tirabrutinib alone compared with rituximab and temozolomide (R-TMZ) combination therapy in participants with Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (IGNITE) is comparing two treatments — tirabrutinib (a targeted pill) versus a chemotherapy combination (rituximab and temozolomide) — for people with primary central nervous system lymphoma (a rare blood cancer in the brain) that has come back after treatment. **You may be eligible if...** - You have been diagnosed with B-cell lymphoma that started in the brain or spinal fluid - Your lymphoma has come back or did not respond after at least one prior treatment containing high-dose methotrexate - You have at least one measurable tumor in the brain visible on MRI - Your overall health, kidney, liver, and bone marrow function are adequate **You may NOT be eligible if...** - Your lymphoma is not confirmed as B-cell type in the central nervous system - You have severe organ problems preventing treatment - You require systemic corticosteroids at high doses 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

DRUGTirabrutinib

Administered orally.

DRUGRituximab

Administered intravenously (IV).

DRUGTemozolomide

Administered orally.


Locations(8)

HonorHealth Cancer Center

Scottsdale, Arizona, United States

Providence Medical Foundation

Fullerton, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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

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NCT07104032


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