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

This clinical trial is being performed to study a drug called tirabrutinib in the treatment of Primary Central Nervous System Lymphoma (PCNSL). PCNSL is a rare cancer that occurs within tissues of the brain, usually without cancerous lesions in other parts of the body. The purpose of this study is to learn how well tirabrutinib (the investigational study drug) works against cancer as compared to the combination of rituximab and temozolomide (comparators) in participants with PCNSL. The study is also being done to learn more about the safety of tirabrutinib and to look at how tirabrutinib may affect the body. This study is for patients with relapsed or refractory (R/R) disease (disease that has not responded or has progressed on the last prior therapy). In the USA, there are no drug therapies specifically approved for the treatment of PCNSL. Tirabrutinib is an investigational drug, which means that it has not been approved by the United States (US) Food and Drug Administration (FDA). Rituximab and temozolomide are approved products by the US FDA and other regulatory agencies for the treatment of cancers other than PCNSL. The combination of rituximab and temozolomide has been assessed in PCNSL in small studies and while it does not have FDA approval for PCNSL, experts list it as one of the treatment options for PCNSL.

Are you Eligible? (Inclusion Criteria)

• Must have a diagnosis of relapsed or refractory B-cell Primary Central Nervous System Lymphoma (PCNSL) with at least 1 prior treatment with high-dose methotrexate-based therapy for PCNSL. 2. Must be 18 years of age or older. 3. Must have a pathology report confirming the diagnosis of B-cell PCNSL.