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Clinical Trials in the USA / NCT07104032
Recruiting Phase 3

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

NCT07104032 · tracked via the Priya Life Science USA tracker
Sponsor
Ono Pharmaceutical Co., Ltd.
Phase
Phase 3
Started
2026-06-12
Last updated
2026-09-03

Condition(s) studied

Relapsed/Refractory Primary Central Nervous System Lymphoma

Investigational drug(s) / intervention(s)

TirabrutinibRituximabTemozolomide

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (33)

FacilityCityRegionStatus
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
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
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 the USA

Official registry record

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 the USA