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).
Pathology report confirming the diagnosis of B-cell 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.
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)
Participants with isolated intraocular PCNSL or spinal PCNSL with no brain lesions
Participants with non-B-cell PCNSL
Participants with systemic presence of lymphoma
Refractory to temozolomide with or without rituximab-containing regimens in the last PCNSL treatment
Ono Pharmaceutical Co., Ltd.
Lead sponsor
Deciphera Pharmaceuticals, LLC
Collaborator