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
Ono Pharmaceutical Co., Ltd.
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
- Age range
- 18+ years
- Sex
- All
- 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…
Interventions
- DrugTirabrutinib
Administered orally.
- DrugRituximab
Administered intravenously (IV).
- DrugTemozolomide
Administered orally.
Locations (8)
- HonorHealth Cancer CenterScottsdale, Arizona
- Providence Medical FoundationFullerton, California
- Yale Cancer CenterNew Haven, Connecticut
- Massachusetts General HospitalBoston, Massachusetts
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts