NCT07104032 · Ono Pharmaceutical Co., Ltd.
IGNITE: Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)
(IGNITE)
What this study is about
The purpose of this clinical trial is to evaluate effectiveness and safety of tirabrutinib alone compared with rituximab and temozolomide (R-TMZ) two or more treatments used together in participants with Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL).
View original scientific description
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- Phoenix, Arizona
- Scottsdale, Arizona
- Fullerton, California
- Orange, California
- New Haven, Connecticut
- Washington D.C., District of Columbia
- Jacksonville, Florida
- Boston, Massachusetts
- Rochester, Minnesota
- Hackensack, New Jersey
- Summit, New Jersey
- New York, New York
And 4 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2026 · Source of record for eligibility and locations