A Phase 2 Trial Comparing Sintilimab Plus P-GEMOX Versus P-GEMOX Alone for Newly Diagnosed Advanced Extranodal Natural KillerT-Cell Lymphoma

What this Trial Is About

Researchers are evaluating treatments for advanced extranodal natural killerT-cell lymphoma ENKTL, a rare and aggressive type of non-Hodgkin lymphoma with poor prognosis in advanced stages. This phase 2 randomized trial aims to assess the effectiveness and safety of combining sintilimab, a PD-1 antibody, with chemotherapy compared to chemotherapy alone as a first-line treatment. The study also investigates biomarkers that might predict patient responses, potentially offering new therapeutic options for ENKTL patients. The trial compares two treatment groups one receives sintilimab intravenously combined with the P-GEMOX chemotherapy regimen, which includes pegaspargase intramuscular injection, gemcitabine, and oxaliplatin both intravenous drips. The other group receives the P-GEMOX regimen alone. This study involves multiple centers and follows patients under these treatments to evaluate outcomes over time. Participants must be adults with newly diagnosed advanced ENKTL and at least one measurable lesion. They will be monitored for progression-free survival up to four years as the primary outcome, alongside secondary outcomes such as overall response, complete remission, overall survival, and adverse events. Assessments include clinical evaluations, laboratory tests, and safety monitoring throughout the study duration, with informed consent and eligibility confirmed before enrollment.

Sintilimab With P-GEMOX Versus the P-GEMOX in the Teatment of Advanced-stage Extranodal Natural Killer/T Cell Lymphoma