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

Phase 3 Recruiting 132 enrolled Ono Pharmaceutical Co., Ltd. Deciphera Pharmaceuticals, LLC · collab

RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start: 2026-06-12
Primary completion: 2027-12
Completion: 2029-12

Publications

Nayak L, Grommes C, Psoinos C, Reu FJ, Takazawa A, Uttarwar M, Xia B, Carvajal LA, Kim S, Sherman ML, Batchelor TT. IGNITE: a phase III study of tirabrutinib versus rituximab and temozolomide combination therapy in relapsed/refractory primary central nervous system lymphoma. Future Oncol. 2026 Jun;22(15):1751-1757. doi: 10.1080/14796694.2026.2683574. Epub 2026 Jun 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous
Comparator	Temozolomide	Small molecule	150 mg/m2	Oral
Subject	Tirabrutinib	Small molecule	480 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications