Study of Selinexor with COPL Chemotherapy in Newly Diagnosed Advanced NKT-cell Lymphoma Patients

What this Trial Is About

Researchers are studying patients with newly diagnosed, pathologically confirmed advanced NKT-cell lymphoma at stage III or IV. This study evaluates the combination of the XPO1 inhibitor Selinexor with the COPL chemotherapy regimen over multiple cycles. The purpose is to assess the response rate and safety of this treatment approach in this patient group. The treatment involves the XCOPL regimen consisting of Selinexor taken orally at 60 mg on days 1, 8, and 15 of a 3-week cycle, combined with other chemotherapy agents. Patients receive 6 to 8 cycles of this regimen. After 3 cycles, safety and PET-CT scans assess treatment response. Those achieving partial remission or better continue the original regimen. Patients without sufficient response undergo re-biopsy and may be excluded. After 6 cycles, those still in partial remission may switch to a second-line regimen including GDP combined with Selinexor. Treatment may continue up to 8 cycles, followed by hematopoietic stem cell transplantation and a follow-up period. During the study, participants undergo regular assessments including ultrasound or CT scans, peripheral blood tests for ctDNA and EBV copy number every 3 months in the first year, and PET-CT scans every 6 months. The main outcomes measured are the 1-year response rate and incidence of treatment-emergent adverse events. Secondary outcomes include progression-free survival, overall survival, and blood markers. Follow-up continues after treatment completion to monitor long-term effects and disease status.

Clinical Study of XPO1 Inhibitor Selinexor Combined With COPL in Newly Diagnosed Advanced NK/T-cell Lymphoma