PD-1 Inhibitor Failed Patients With Classical Hodgkin Lymphoma Clinical Trial
Official title:
A Randomized, Open-label, Phase 2 Trial of Chidamide+Decitabine Plus Anti-PD-1 Antibody in PD-1 Inhibitor Failed Patients With Classical Hodgkin Lymphoma.
The issue of therapy after PD-1 inhibitor failure is unresolved in classic Hodgkin lymphoma. Preliminary clinical observations have shown that patients might benefit from Chidamide+Decitabine plus anti-PD-1 antibody. This open-label, randomized, phase 2 study aims to evaluate the efficacy of Chidamide+Decitabine plus anti-PD-1 and the standard of care, which includes anti-PD-1 antibody, in patients with classical Hodgkin lymphoma who have experienced failure with PD-1 inhibitor. The primary objective of the study is to evaluate the 12-month progression-free survival rates.
Anti-PD-1 antibody induces a high response rate in patients with relapsed/refractory classic Hodgkin lymphoma, but more than 60% of patients have disease relapse or progression during or after immune checkpoint inhibitors and subsequent salvage therapies could not meet the need. Preliminary clinical observations have shown that Chidamide+Decitabine plus anti-PD-1 antibody might be beneficial for these patients. This open-label, randomized, phase 2 study aims to evaluate the efficacy of Chidamide+Decitabine plus anti-PD-1 antibody and the standard of care, which includes anti-PD-1 antibody, in patients with classical Hodgkin lymphoma who have experienced failure with PD-1 inhibitor. The standard of care involves Gemcitabine, Vinorelbine, and Pegylated liposomal doxorubicin (GVD) or Ifosfamide, Carboplatin, and Etoposide (ICE) or Brentuximab Vedotin (BV) plus PD-1 inhibitor. The specific regimen will be determined by investigators. The primary objective of the study is to evaluate the 12-month progression-free survival rates. The key secondary end points are complete response rate, objective response rate and the safety. ;