Phase 2 Study of Sintilimab, Pegaspargase with Gemcitabine and Oxaliplatin P-P-GEMOX as First Treatment for Extranodal NKT-Cell Lymphoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a treatment combining sintilimab, pegaspargase, gemcitabine, and oxaliplatin called the P-P-GEMOX regimen as a first treatment for patients newly diagnosed with extranodal NKT-cell lymphoma ENKTL. This phase 2 study aims to measure the complete response rate after treatment. Secondary goals include overall response rate, progression-free survival, overall survival, and monitoring of side effects. Patients receive the P-P-GEMOX regimen every three weeks. Those with early-stage disease stage I-II first get two cycles of treatment, followed by radiotherapy if they respond, and then two more cycles afterward. Patients with advanced disease stage III-IV receive six cycles of treatment. If they respond well, further options such as stem cell transplantation or maintenance therapy with PD-1 monoclonal antibody may be considered based on age and physical condition. Participants will be closely monitored with evaluations after three treatment cycles and one month after finishing therapy to determine response. Safety is assessed through tracking adverse events during treatment and for 28 days after the last cycle. Progression-free survival and overall survival will be followed for up to three years from enrollment to understand longer-term outcomes. The study is sponsored by Peking Union Medical College Hospital and runs until May 2027.

Sintilimab, Pegaspargase Plus GemOx for Untreated Extranodal NK/T-Cell Lymphoma