Tirabrutinib Maintenance Versus Placebo in Patients With Primary CNS Lymphoma in Complete Remission (JCOG2104)

A double-blind, randomized phase II comparative trial will evaluate the superiority of the investigational treatment (tirabrutinib maintenance therapy) over standard care (observation with placebo) in terms of progression-free survival in patients with newly diagnosed primary central nervous system lymphoma (PCNSL) who have achieved complete response (CR or CRu) following induction therapy with high-dose methotrexate (HD-MTX)-based chemotherapy and have not undergone consolidative whole-brain irradiation. Participants will: Take protocol drug tirabrutinib or a placebo every day until disease progression or experience of unacceptable toxicity. Visit the clinic once every 4 weeks for checkups and tests, as well as protocol drug prescription.

NCT Number	NCT06940791
Lead Sponsor	Kyorin University Collaborators: National Cancer Center, Japan, Ono Pharmaceutical Co., Ltd., Japan Clinical Oncology Group
Conditions	Primary Central Nervous System Lymphoma
Enrollment	92 participants
Start Date	2023-10-06
Primary Completion	2030-02 (estimated)
Study Completion	2030-02 (estimated)
Updated on ClinicalTrials.gov	2026-08-05