Phase 2 Study of Rituximab, Pirtobrutinib, High-Dose Methotrexate, Dexamethasone, and Thiotepa R-PMDT to Treat Newly Diagnosed Primary Central Nervous System Lymphoma

What this Trial Is About

Researchers are studying treatment for patients with newly diagnosed primary central nervous system lymphoma PCNSL. This open-label, single-arm phase 2 trial aims to evaluate the overall response rate of a combination regimen called R-PMDT, which includes rituximab, pirtobrutinib, high-dose methotrexate, dexamethasone, and thiotepa. Secondary goals include assessing complete response rate, progression-free survival, overall survival, and safety of this treatment. Participants will receive six cycles of the R-PMDT regimen. Rituximab is given as an intravenous infusion on day 0 methotrexate as a 3-hour intravenous infusion on day 1 with dose adjustments based on kidney function dexamethasone intravenously on days 1 to 4 thiotepa intravenously on day 1 and pirtobrutinib orally daily from days 4 to 21 or until the day before the next methotrexate dose. After six cycles, patients may receive additional consolidation or maintenance therapies, like stem cell transplantation, radiotherapy, or pirtobrutinib maintenance, as decided by the investigator. Throughout the study, participants will be closely monitored to assess response to treatment and safety. Researchers will evaluate outcomes such as overall response rate, complete response rate, progression-free survival, and overall survival for up to two years. The study involves regular clinical assessments, laboratory tests, and imaging as needed to track treatment effects and monitor patient health during and after the regimen.

R-PMDT Regimen in Newly Diagnosed PCNSL