Trial in progress: A phase 3, multi-regional, open-label, randomized study of tirabrutinib vs rituximab and temozolomide in participants with Relapsed/Refractory primary central nervous system lymphoma
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Overview
Phase 3 trial compares tirabrutinib and rituximab-temozolomide in relapsed/refractory PCNSL, revealing potential benefits for patients.
Key Points
- To determine the clinical benefits of tirabrutinib compared to rituximab-temozolomide in relapsed/refractory primary CNS lymphoma (PCNSL).
- Phase 3, open-label, randomized trial design
- Enrolling approximately 132 adult patients with relapsed/refractory B-cell PCNSL
- Patients randomized to receive tirabrutinib or rituximab-temozolomide combination therapy
- Eligibility criteria include pathologically confirmed diagnosis and prior HD-MTX therapy
- Primary endpoint is progression-free survival based on independent review.
- Overall response rate for tirabrutinib was reported at 67% in prior studies
- Primary endpoint of progression-free survival assessed for treatment comparison
- Secondary endpoints include overall survival and complete response rate.
Cite This Study
Grommes et al. (2025) studied this question.