Study of Methotrexate with Rituximab, Sintilimab, and Pirtobrutinib Compared to Standard Methotrexate-Based Care in Adults with Newly Diagnosed Primary Central Nervous System Lymphoma

What this Trial Is About

Researchers are evaluating a new four-drug combination as a first treatment for adults 18 years and older with newly diagnosed primary central nervous system lymphoma PCNSL, a rare form of lymphoma affecting the brain and eyes. This study aims to see if combining pirtobrutinib, sintilimab, rituximab, and high-dose methotrexate can improve the complete response rate compared to standard high-dose methotrexate-based treatments, while also assessing safety and tolerability. The research compares this new treatment to commonly used regimens chosen by doctors to improve patient outcomes. Participants receive either the experimental four-drug combination or one of three standard treatment options selected by their doctor, each given in 6 cycles lasting 21 days each. The experimental group receives rituximab, methotrexate, sintilimab, and pirtobrutinib with specific dosing schedules, while the standard treatments include various combinations of rituximab, methotrexate, cytarabine, temozolomide, or covalent BTK inhibitors. Some patients may also receive additional consolidation or maintenance therapy depending on their response. Throughout the study, participants undergo regular clinical assessments including brain MRI scans with contrast, blood tests, and cerebrospinal fluid exams. They complete quality-of-life questionnaires at set points during and after treatment. Researchers monitor treatment response, progression-free and overall survival, adverse events, and patient-reported outcomes. Follow-up lasts up to two years after treatment to assess long-term effects and disease progression, with some outcomes tracked up to five years.

A Multicenter, Prospective Clinical Trial With a Concurrent Control Evaluating Methotrexate Combined With Rituximab,Sintilimab and Pirtobrutinib vs. Investigator-Selected Standard of Care in Treatment-Naive PCNSL