IGNITE: Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)
Condition(s) studied
Investigational drug(s) / intervention(s)
Tirabrutinib: Administered orally.
Rituximab: Administered intravenously (IV).
Temozolomide: Administered orally.
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).
Eligibility
Primary outcome measure(s)
- Progression Free Survival (PFS) — Estimated up to 24 months
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.
Trial sites (36)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic Cancer Center | Phoenix | Arizona | Recruiting |
| HonorHealth Cancer Center | Scottsdale | Arizona | Recruiting |
| Providence Medical Foundation | Fullerton | California | Recruiting |
| UC Irvine Health | Orange | California | Recruiting |
| Yale Cancer Center | New Haven | Connecticut | Recruiting |
| John Hopkins University | Washington D.C. | District of Columbia | Recruiting |
| University of Florida Gainesville | Gainesville | Florida | Recruiting |
| Mayo Clinic Cancer Center | Jacksonville | Florida | Recruiting |
| University of Maryland | Baltimore | Maryland | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | Recruiting |
| Dana-Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| Mayo Clinic Cancer Center | Rochester | Minnesota | Recruiting |
| Hackensack University Medical Center | Hackensack | New Jersey | Recruiting |
| Atlantic Health Overlook Medical Center | Summit | New Jersey | Recruiting |
| NYU Langone Health | New York | New York | Recruiting |
| Columbia University Irving Medical Center | New York | New York | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| Duke University Medical Center | Durham | North Carolina | Recruiting |
| Providence Neurological Specialties West | Portland | Oregon | Recruiting |
| Penn State Health Milton S Hershey Medical Center | Hershey | Pennsylvania | Recruiting |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | Recruiting |
| Rhode Island Hospital | Providence | Rhode Island | Recruiting |
| University of Washington | Seattle | Washington | Recruiting |
| Epworth Healthcare | Melbourne | Victoria | Recruiting |
| Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein | São Paulo | Brazil | Recruiting |
| University Hospital Ostrava | Ostrava | Czechia | Recruiting |
| University Hospital Královské Vinohrady | Prague | Czechia | Recruiting |
| Hôpitaux de Marseille | Marseille | France | Recruiting |
| Hospital Center University De Montpellier | Montpellier | France | Recruiting |
| ASST Spedali Civili di Brescia | Brescia | Italy | Recruiting |
| IRCCS Istituto Romagnolo per lo studio dei Tumori "Dino Amadori" - IRST | Meldola | Italy | Recruiting |
| Arcispedale S. Maria Nuova | Reggio Emilia | Italy | Recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Recruiting |
| Hospital Clínic de Barcelona | Barcelona | Spain | Recruiting |
| Hospital Universitario 12 De Octubre | Madrid | Spain | Recruiting |
On this site
📄 Rituxan (rituximab) drug profile →More Ono Pharmaceutical Co., Ltd. trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07104032 on ClinicalTrials.gov ↗ ← All trials in Italy