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IGNITE: Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)
Sponsor: Ono Pharmaceutical Co., Ltd.
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
Tirabrutinib
Administered orally.
Rituximab
Administered intravenously (IV).
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