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RECRUITING
NCT07104032
PHASE3

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

Sponsor: Ono Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2026-06-12

Completion Date

2029-12

Last Updated

2026-07-10

Healthy Volunteers

No

Interventions

DRUG

Tirabrutinib

Administered orally.

DRUG

Rituximab

Administered intravenously (IV).

DRUG

Temozolomide

Administered orally.

Locations (20)

Mayo Clinic Cancer Center

Phoenix, Arizona, United States

HonorHealth Cancer Center

Scottsdale, Arizona, United States

Providence Medical Foundation

Fullerton, California, United States

UC Irvine Health

Orange, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

John Hopkins University

Washington D.C., District of Columbia, United States

Mayo Clinic Cancer Center

Jacksonville, Florida, 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

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Atlantic Health Overlook Medical Center

Summit, New Jersey, United States

NYU Langone Health

New York, New York, United States

Columbia University Irving Medical Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Providence Neurological Specialties West

Portland, Oregon, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States