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RECRUITING
NCT06393361
PHASE2

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

Sponsor: Chinese PLA General Hospital

View on ClinicalTrials.gov

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 plus Anti-PD-1 Antibody in transplant-ineligible or refused transplant diagnosedR/R cHL. The primary objective of the study is to evaluate progression-free survival.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-06-01

Completion Date

2027-06-01

Last Updated

2026-01-02

Healthy Volunteers

No

Interventions

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, anti-PD-1 antibody.

Brentuximab Vedotin 1.8mg/kg d1, anti-PD-1 antibody d1. Physicians will decide which immune checkpoint inhibitors will be used during treatment.

Locations (1)

Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital

Beijing, China