Tirabrutinib versus rituximab plus temozolomide for relapsed or refractory primary central nervous system lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3, interventional trial compares tirabrutinib monotherapy against the combination of rituximab and temozolomide in adults with relapsed or refractory B‑cell primary CNS lymphoma. Participants must have had at least one prior high‑dose methotrexate–based regimen and measurable brain lesions on contrast MRI. The study will follow patients for response and safety outcomes to determine whether tirabrutinib provides superior disease control or a different safety profile compared with R‑TMZ. Multiple U.S. cancer centers are participating under sponsorship from Ono Pharmaceutical with collaborator support from Deciphera.

Why it matters

Who can join: the full rules

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 measurable brain lesions with a diameter in at least one dimension greater than or equal to (≥) 1 centimeter (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

Where it's running

• 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

Study contacts

• Study coordinator: Clinical Team
• Email: clinicaltrials@deciphera.com
• Phone: 888-724-3274

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.