NCT06563778

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

A Randomized, Open-label, Phase 2 Trial of Chidamide+Decitabine Plus Anti-PD-1 Antibody for Patients With R/R cHL Who Are Transplant-ineligible or Refused Transplant

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The prognosis of refractory or early-relapsed lymphoma is poor, and it is even worse for those who are not eligible or refuse transplantation. Although many salvage regimens have been developed, there is no standard of care. Preliminary clinical observations have shown that Chidamide +Decitabine plus Anti-PD-1 Antibody might be beneficial for these patients. Brentuximab Vedotin or Bendamustine plus Anti-PD-1 Antibody are both standard regimens.The combination of Brentuximab Vedotin, Bendamustine and Anti-PD-1 Antibody may be another effective regimen. 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 patients with classical Hodgkin lymphoma who are transplant-ineligible or refused transplant . The primary objective of the study is to evaluate the progression free survival. The key secondary end points are complete response rate, objective response rate and the safety.

Conditions

• Ineligible Or Refused Transplant Patients With Classical Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Chidamide; Decitabine; Anti-PD-1 Antibody	Chidamide 10mg/day, day1-4; 20mg/day, day 8,11, 15, 18. Decitabine 10mg/day, day1-5. Physicians will decide which immune checkpoint inhibitors will be used during treatment.
DRUG	Brentuximab Vedotin+ Bendamustine+Anti-PD-1 antibody	Brentuximab Vedotin 1.2-1.8mg/kg day 1, Bendamustine 70-90mg/m2 day1-2, Anti-PD-1 antibody day 2. Physicians will decide which immune checkpoint inhibitors will be used during treatment.

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-09-01
• Completion: 2028-09-01
• First posted: 2024-08-21
• Last updated: 2024-08-21

Locations

1 site across 1 country: China