🏛️ Verified NIH Protocol • Sourced via U.S. National Library of Medicine (Last Synced: 2026-08-18)

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

🟢 Recruiting Phase 3 💊 Investigational Drug / Biologic Sponsor: Ono Pharmaceutical Co., Ltd.

🩺 Protocol 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 Research Facility: Mayo Clinic Cancer Center (Phoenix, Arizona)

📋 Preliminary Self-Screener

0 of 3 Answered

Answer all 3 basic criteria below to see your preliminary screening result:

Diagnosed with or currently undergoing clinical evaluation for **Primary Central Nervous System Lymphoma (PCNSL)**?

Aged **18 Years or older**?

Able to attend study appointments at **Mayo Clinic Cancer Center** (Phoenix, Arizona) or affiliated sites?

📍 Primary Site Map

Site: Mayo Clinic Cancer Center — Phoenix, Arizona

📍 All Participating Trial Locations (32 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. Mayo Clinic Cancer Center — Phoenix, Arizona • Contact: (480) 574-3222

2. HonorHealth Cancer Center — Scottsdale, Arizona • Contact: (602) 258-2863

3. Providence Medical Foundation — Fullerton, California • Contact: (714) 992-3000

4. UC Irvine Health — Orange, California • Contact: (714) 509-2370

5. Yale Cancer Center — New Haven, Connecticut • Contact: (203) 260-9632

6. John Hopkins University — Washington D.C., District of Columbia • Contact: (202) 660-5879

7. University of Florida Gainesville — Gainesville, Florida • Contact: (352) 273-6945

8. Mayo Clinic Cancer Center — Jacksonville, Florida • Contact: (904) 953-5288

9. University of Maryland — Baltimore, Maryland • Contact: (410) 328-7931

10. Massachusetts General Hospital — Boston, Massachusetts • Contact: (617) 726-1114

11. Beth Israel Deaconess Medical Center — Boston, Massachusetts • Contact: (617) 667-7000

12. Dana-Farber Cancer Institute — Boston, Massachusetts • Contact: (617) 582-9314

13. Mayo Clinic Cancer Center — Rochester, Minnesota • Contact: (507) 538-3227

14. Hackensack University Medical Center — Hackensack, New Jersey • Contact: (551) 996-8120

15. Atlantic Health Overlook Medical Center — Summit, New Jersey • Contact: (908) 522-5985

16. NYU Langone Health — New York, New York • Contact: (347) 449-0107

17. Columbia University Irving Medical Center — New York, New York • Contact: (212) 304-6329

18. Memorial Sloan Kettering Cancer Center — New York, New York • Contact: (901) 883-8400

19. Duke University Medical Center — Durham, North Carolina • Contact: (919) 668-6230

20. Providence Neurological Specialties West — Portland, Oregon • Contact: (503) 216-1157

21. Penn State Health Milton S Hershey Medical Center — Hershey, Pennsylvania • Contact: (717) 531-0003

22. UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania • Contact: (878) 261-6727

23. Rhode Island Hospital — Providence, Rhode Island • Contact: (401) 444-4822

24. Epworth Healthcare — Melbourne, Victoria • Contact: (039) 516-2374

25. University Hospital Ostrava — Ostrava, Czechia • Contact: +420 597372151

📄 Print Doctor Discussion Sheet

Preview and print a 1-page summary with 5 tailored questions for your physician.

💰 Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act § 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

💡 Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

🏛️ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT07104032 • Last Synced: 2026-08-18

View on ClinicalTrials.gov ↗