drugset / Trial / NCT06563778

Chidamide+Decitabine Plus Anti-PD-1 Antibody for Patients With R/R cHL Who Are Transplant-ineligible or Refused Transplant.

NCT06563778

Phase 2 Not yet recruiting 100 enrolled Chinese PLA General Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

The prognosis for patients with relapsed/refractory classical Hodgkin lymphoma (cHL) who refuse or are ineligible for transplant is poor. This open label, randomized, phase 2 study aims to evaluate the efficacy of Chidamide+Decitabine plus Anti-PD-1 Antibody and Brentuximab Vedotin + Bendamustine plus Anti-PD-1 Antibody in transplant-ineligible or refused transplant diagnosed R/R cHL. The primary objective of the study is to evaluate progression-free survival.

Timeline

Start
2024-09-01
Primary completion
2026-09-01
Completion
2028-09-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bendamustine Small molecule 70 mg/m2
Comparator Bendamustine Small molecule 90 mg/m2
Comparator Brentuximab Vedotin Monoclonal antibody 1.2 mg/kg
Comparator Brentuximab Vedotin Monoclonal antibody 1.8 mg/kg
Subject Decitabine Small molecule 10 mg
Subject Tucidinostat Small molecule 20 mg