A Multicenter Two-Cohort Study of Methotrexate, Rituximab, Sintilimab and Pirtobrutinib for Treatment-Naive PCNSL vs. Real-World Investigator-Selected Treatment (Observational Cohort)

• Status: RECRUITING
• Trial end date: 2029-06-30

Summary

The goal of this clinical trial is to evaluate a new combination therapy for patients with newly diagnosed Primary Central Nervous System Lymphoma (PCNSL). The main questions it aims to answer are: (1) Does the combination of Methotrexate, Rituximab, Sintilimab, and Pirtobrutinib improve the Complete Remission Rate (CRR)? (2) Is this regimen safe and tolerable for patients? Researchers will compare this interventional group to a real-world observational group (receiving standard investigator-selected treatments) to see if the new combination improves treatment response and survival.

• Phase: PHASE2

Details

• Lead Sponsor: Tongji Hospital
• Collaborators: China-Japan Union Hospital, Jilin University; First Affiliated Hospital of Fujian Medical University; Shanxi Provincial People's Hospital; The General Hospital of Western Theater Command
• Treatments: Methotrexate; pirtobrutinib; Rituximab; sintilimab; Standard of Care