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NCT07104032

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Ono Pharmaceutical Co., Ltd.
~132 participants
Updated 2026-09-03 on ClinicalTrials.gov
What's tested:TirabrutinibRituximabTemozolomide

At a glance

Recruiting sites
33 of 33 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival (PFS)
Measured over Estimated up to 24 months

Conditions

Relapsed/Refractory Primary Central Nervous System Lymphoma

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Primary Central Nervous System Lymphoma

NCT07104032

Where you'd take part

This study runs at 33 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • ASST Spedali Civili di Brescia

    Brescia, Italy, Italystudy coordinator listed

    Recruiting

  • Atlantic Health Overlook Medical Center

    Summit, New Jerseystudy coordinator listed

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Columbia University Irving Medical Center

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Duke University Medical Center

    Durham, North Carolinastudy coordinator listed

    Recruiting

  • Epworth Healthcare

    Melbourne, Victoria, Australiastudy coordinator listed

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jerseystudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Clinical Team · STUDY_DIRECTOR · Deciphera Pharmaceuticals, LLC

Who to contact

Clinical Team
[email protected]
888-724-3274
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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 trial measures

  • Progression Free Survival (PFS)Estimated up to 24 months

    PFS based on blinded Independent Review Committee (BIRC) assessment according to International Primary Central Nervous System Lymphoma Collaborative Group (IPCG) criteria, defined as time from randomization to progressive disease (PD) or death due to any cause, whichever occurs first.