OncRef

Clinical Trial: NCT07104032

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

Status:

RECRUITING

Phase:

Phase 3

Lead Sponsor:Ono Pharmaceutical Co., Ltd.
Information Provided By:Ono Pharmaceutical Co., Ltd.
Last Update Posted:2026-10-20

Study Overview

Brief 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, Multiregional, Open-label, Randomized Study of Tirabrutinib vs Rituximab and Temozolomide in Participants With Relapsed/Refractory Primary Central Nervous System Lymphoma (IGNITE)

Conditions

Relapsed/Refractory Primary Central Nervous System Lymphoma

Intervention / Treatment

  • Drug: Tirabrutinib
  • Drug: Rituximab
  • Drug: Temozolomide

Other Study ID Numbers

  • ONO-4059-17
  • 2025-523389-26-00
  • 2025

Start Date (Actual)

2026-06-12

Primary Completion Date (Estimated)

2027-12

Study Completion Date (Estimated)

2029-12

Enrollment (Estimated)

132

Study Type

Interventional

Phase

Phase 3