NCT07104032

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Ono Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Relapsed/Refractory Primary Central Nervous System Lymphoma

Interventions

Type	Name	Description
DRUG	Tirabrutinib	Administered orally.
DRUG	Rituximab	Administered intravenously (IV).
DRUG	Temozolomide	Administered orally.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-12-01
• Completion: 2029-12-01
• First posted: 2025-08-05
• Last updated: 2026-03-11

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study