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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
2026-05
Completion Date
2029-12
Last Updated
2026-05-20
Healthy Volunteers
No
Interventions
Tirabrutinib
Administered orally.
Rituximab
Administered intravenously (IV).
Temozolomide
Administered orally.
Locations (10)
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
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