Safety and Effectiveness of Pomadomide with Rituximab and Methotrexate for Newly Diagnosed Primary Central Nervous System Lymphoma A Phase III Multicenter Study

What this Trial Is About

Researchers are evaluating the safety and efficacy of pomadomide combined with rituximab and methotrexate PRM regimen in people newly diagnosed with primary central nervous system lymphoma PCNSL, a type of lymphoma confined to the brain, spinal cord, eyes, or meninges. This Phase IbII, prospective, multicenter, open-label study includes a dose escalation phase to find the maximum tolerated dose of pomadomide and a second phase to further assess treatment effects and safety in more participants. Participants receive induction treatment with the PRM regimen for 4 cycles, where pomadomide doses range from 3mg to 5mg once daily for 14 days every 21 days, rituximab given by intravenous infusion at 375mgm2 on day 1 every 3 weeks, and methotrexate given by intravenous infusion at 3.5gm2 over 4 hours on day 1 every 21 days. Those who achieve complete or partial remission then receive consolidation treatment either with autologous transplantation or the original regimen for 2 additional cycles, followed by pomadomide maintenance therapy for 12 cycles. Throughout the study, participants undergo assessments including imaging scans to measure disease response and laboratory tests to monitor health. The main outcomes measured are the maximum tolerated dose of pomadomide and the objective response rate after 4 cycles. Secondary outcomes include progression-free survival for up to 2 years and overall survival for up to 3 years. Follow-up care and evaluations continue for up to 3 years after treatment to monitor long-term effects and disease status.

A Study of Pomadomide in Combination With Rituximab and Methotrexate for Newly-diagnosed Primary Central Nervous System Lymphoma