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

Recruiting now · Phase 3

Conditions studied: Relapsed/Refractory Primary Central Nervous System Lymphoma

In brief

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).

Key facts

Study ID

NCT07104032

Run by

Ono Pharmaceutical Co., Ltd.

People needed

132

Starts

2026-06-12

Expected to finish

2029-12-01

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathology report confirming the diagnosis of B-cell PCNSL
• 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.
• 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)
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2
• Adequate bone marrow, renal, and hepatic function per central lab values
• Participants must agree to comply with all defined contraceptive requirements

You may not qualify if…

• Participants with isolated intraocular PCNSL or spinal PCNSL with no brain lesions
• Participants with non-B-cell PCNSL
• Participants with systemic presence of lymphoma
• Refractory to temozolomide with or without rituximab-containing regimens in the last PCNSL treatment
• 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
• Active malignancy, other than PCNSL requiring systemic therapy
• Poorly controlled comorbidity, or history of medical conditions contraindicated per Investigator assessment
• Participants who are unable to swallow oral medication
• Prior Bruton's tyrosine kinase inhibitor treatment

Where it is running

• Mayo Clinic Cancer Center — Phoenix, Arizona, United States (enrolling)
• HonorHealth Cancer Center — Scottsdale, Arizona, United States (enrolling)
• Providence Medical Foundation — Fullerton, California, United States (enrolling)
• UC Irvine Health — Orange, California, United States (enrolling)
• Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
• John Hopkins University — Washington D.C., District of Columbia, United States (enrolling)
• University of Florida Gainesville — Gainesville, Florida, United States (enrolling)
• Mayo Clinic Cancer Center — Jacksonville, Florida, United States (enrolling)
• University of Maryland — Baltimore, Maryland, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Mayo Clinic Cancer Center — Rochester, Minnesota, United States (enrolling)
• Hackensack University Medical Center — Hackensack, New Jersey, United States (enrolling)
• Atlantic Health Overlook Medical Center — Summit, New Jersey, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• Columbia University Irving Medical Center — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Duke University Medical Center — Durham, North Carolina, United States (enrolling)
• Providence Neurological Specialties West — Portland, Oregon, United States (enrolling)
• Penn State Health Milton S Hershey Medical Center — Hershey, Pennsylvania, United States (enrolling)
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (enrolling)
• Rhode Island Hospital — Providence, Rhode Island, United States (enrolling)
• University Hospital Ostrava — Ostrava, Czechia, Czechia (enrolling)
• Hôpitaux de Marseille — Marseille, France, France (enrolling)

Full record on ClinicalTrials.gov

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