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NCT07104032 · ClinicalTrials.gov registry record · Phase 3
IGNITE: Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)
A Phase 3 study of Relapsed/Refractory Primary Central Nervous System Lymphoma, sponsored by Ono Pharmaceutical Co..
- Recruiting
- Registry status
- Phase 3
- Development phase
- 132
- Enrollment target
- 4
- Study locations
NCT07104032: Recruiting Phase 3 study of Relapsed/Refractory Primary Central Nervous System Lymphoma, sponsored by Ono Pharmaceutical Co..
NCT07104032 is a Phase 3 study of Relapsed/Refractory Primary Central Nervous System Lymphoma that is actively recruiting participants, run by Ono Pharmaceutical Co.. The registered enrollment target is 132 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07104032, a Phase 3 study of Relapsed/Refractory Primary Central Nervous System Lymphoma, is actively recruiting participants, sponsored by Ono Pharmaceutical Co..
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 132 participants
- Enrollment target
- 4
- Study locations
Study 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).
Primary Outcome
PFS based on blinded Independent Review Committee (BIRC) assessment according to International Primary Central Nervous System Lymphoma Collaborative Group (IPCG) criteria, defined as time from randomization to progressive disease (PD) or death due to any cause, whichever occurs first.
Conditions Studied
Interventions
- DRUG Rituximab
- DRUG Temozolomide
- DRUG Tirabrutinib
Study Locations (4)
Arizona
- HonorHealth Cancer Center - Scottsdale
Connecticut
- Yale Cancer Center - New Haven
New York
- Memorial Sloan Kettering Cancer Center - New York
Pennsylvania
- UPMC Hillman Cancer Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2026-03 |
| Est. Completion | 2029-12 |
| Phase | Phase 3 |
What NCT07104032 shows while recruiting
NCT07104032 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Relapsed/Refractory Primary Central Nervous System Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which Rituximab is the first listed.
NCT07104032 reports a single indexed study location in Arizona, Connecticut, New York.
Frequently Asked Questions
What is clinical trial NCT07104032 about?
NCT07104032 is a clinical study titled "IGNITE: Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)". 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).
What is the current status of trial NCT07104032?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 132 participants. The study started on 2026-03. Estimated completion is 2029-12.
What conditions does trial NCT07104032 study?
This clinical trial studies the following conditions: Relapsed/Refractory Primary Central Nervous System Lymphoma.
What interventions are being tested in trial NCT07104032?
The interventions under investigation include: Rituximab (DRUG), Temozolomide (DRUG), Tirabrutinib (DRUG).
Who is sponsoring clinical trial NCT07104032?
This trial is sponsored by Ono Pharmaceutical Co., which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07104032 being conducted?
This trial has 4 study locations across Arizona, Connecticut, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07104032's enrollment target sits among peer trials
132 1589th of 2000 higher than 408 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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