Phase II Study of PD-1 Inhibitors as Maintenance Treatment After Autologous Stem Cell Transplant in Adults With Relapsed or Refractory Classical Hodgkin Lymphoma

What this Trial Is About

Researchers are evaluating the clinical effectiveness of PD-1 inhibitors as maintenance therapy after autologous hematopoietic stem cell transplantation auto-HSCT in patients with relapsed or refractory classical Hodgkin lymphoma cHL. This phase II study focuses on preventing relapse and disease progression in patients who often experience these within two years after auto-HSCT. Current treatments like brentuximab vedotin have improved outcomes but still show limitations, making PD-1 inhibitors a promising alternative due to their favorable toxicity profile and potential for durable remission. Participants will receive maintenance therapy using PD-1 inhibitors, either nivolumab or pembrolizumab, as decided by the study center. Nivolumab is given intravenously either as a fixed 40 mg dose every two weeks for up to 12 cycles or at 3 mgkg every two weeks for up to 12 cycles. Pembrolizumab is administered as a fixed 200 mg dose intravenously every three weeks for up to 8 cycles. Treatment should begin within 60 days after transplantation, with some exceptions allowed under study leadership guidance. Throughout the study, participants will be closely monitored with assessments including imaging scans, blood tests, and evaluation of adverse events. The main outcome measured is progression-free survival at 24 months after starting maintenance therapy, alongside secondary measures such as survival rates and relapse incidence at 12, 18, and 24 months. Safety and tolerability will also be tracked during therapy and for one year after treatment completion. The overall study duration extends to September 2030.

PD-1 Inhibitors Maintenance for cHL Post-autoHCT