Clinical Trial

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

Study acronym: IGNITE
Recruiting Phase 3
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).
Protocol Amendment History 5 changes
notable Trial sites expanded: 20 -> 27 locations 2026-07-30
notable Trial sites expanded: 14 -> 18 locations 2026-06-17
notable Trial sites expanded: 10 -> 14 locations 2026-06-06
notable Trial sites expanded: 4 -> 8 locations 2026-04-28
notable Sponsor changed: Ono Pharmaceutical Co. Ltd -> Ono Pharmaceutical Co., Ltd. 2026-04-19
Trial Details
NCT Number NCT07104032
Lead Sponsor Ono Pharmaceutical Co., Ltd.
Collaborators: Deciphera Pharmaceuticals, LLC
Conditions Relapsed/Refractory Primary Central Nervous System Lymphoma
Enrollment 132 participants
Start Date 2026-06-12
Primary Completion 2027-12 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-05