NCT07104032From ClinicalTrials.govRecruiting

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

Relapsed/Refractory Primary Central Nervous System Lymphoma

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Ono Pharmaceutical Co., Ltd.
Enrolment target: 132
Started: 12 June 2026
Main results due: December 2027
Study sites: 35
Registry updated: 25 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria

1. Pathology report confirming the diagnosis of B-cell PCNSL
2. Relapsed or refractory B-cell PCNSL with at least 1 prior high-dose methotrexate (HD-MTX) based therapy for PCNSL:

* Relapsed disease: Participants who achieved a response (CR, CRu, PR) to the last treatment and subsequently experienced disease progression.
* Refractory disease: Participants whose best response to the last treatment was stable disease or PD.
3. One or more bi-dimensionally measurable brain lesions with a minimum diameter greater than or equal to (≥)1 centimeter (cm) × ≥1 cm in gadolinium-enhanced magnetic resonance imaging (MRI)
4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2
5. Adequate bone marrow, renal, and hepatic function per central lab values
6. Participants must agree to comply with all defined contraceptive requirements

Exclusion Criteria

1. Participants with isolated intraocular PCNSL or spinal PCNSL with no brain lesions
2. Participants with non-B-cell PCNSL
3. Participants with systemic presence of lymphoma
4. Refractory to temozolomide with or without rituximab-containing regimens in the last PCNSL treatment
5. Concomitant systemic corticosteroid exposure within 14 days before starting study drug per Investigator assessment with the exception of the following:

* Equivalent of up to 10 milligram per day (mg/day) of prednisone for a disease other than PCNSL
* Equivalent of up to 50 mg/day of prednisone (equal to 8 mg/day dexamethasone) for participants with lesions of the brain and/or spinal cord
6. Active malignancy, other than PCNSL requiring systemic therapy
7. Poorly controlled comorbidity, or history of medical conditions contraindicated per Investigator assessment
8. Participants who are unable to swallow oral medication
9. Prior Bruton's tyrosine kinase inhibitor treatment

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(35)

Mayo Clinic Cancer Center
Phoenix, Arizona, United States
Recruiting
HonorHealth Cancer Center
Scottsdale, Arizona, United States
Recruiting
Providence Medical Foundation
Fullerton, California, United States
Recruiting
UC Irvine Health
Orange, California, United States
Recruiting
Yale Cancer Center
New Haven, Connecticut, United States
Recruiting
John Hopkins University
Washington D.C., District of Columbia, United States
Recruiting
University of Florida Gainesville
Gainesville, Florida, United States
Recruiting
Mayo Clinic Cancer Center
Jacksonville, Florida, United States
Recruiting
University of Maryland
Baltimore, Maryland, United States
Recruiting
Massachusetts General Hospital
Boston, Massachusetts, United States
Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Recruiting
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, United States
Recruiting
Atlantic Health Overlook Medical Center
Summit, New Jersey, United States
Recruiting
NYU Langone Health
New York, New York, United States
Recruiting
Columbia University Irving Medical Center
New York, New York, United States
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Recruiting
Duke University Medical Center
Durham, North Carolina, United States
Recruiting
Providence Neurological Specialties West
Portland, Oregon, United States
Recruiting
Penn State Health Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Recruiting
Rhode Island Hospital
Providence, Rhode Island, United States
Recruiting
University of Washington
Seattle, Washington, United States
Recruiting
Epworth Healthcare
Melbourne, Victoria, Australia
Recruiting
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, Brazil
Recruiting
University Hospital Ostrava
Ostrava, Czechia, Czechia
Recruiting
University Hospital Královské Vinohrady
Prague, Czechia, Czechia
Recruiting
Hôpitaux de Marseille
Marseille, France, France
Recruiting
Hospital Center University De Montpellier
Montpellier, France, France
Recruiting
ASST Spedali Civili di Brescia
Brescia, Italy, Italy
Recruiting
IRCCS Istituto Romagnolo per lo studio dei Tumori "Dino Amadori" - IRST
Meldola, Italy, Italy
Recruiting
Arcispedale S. Maria Nuova
Reggio Emilia, Italy
Recruiting
Hospital Clínic de Barcelona
Barcelona, Spain, Spain
Recruiting
Hospital Universitario 12 De Octubre
Madrid, Spain, Spain
Recruiting

Showing 35 of 35 sites. 35 of the 35 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07104032. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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