Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06393361

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

Led by Chinese PLA General Hospital · Updated on 2026-01-02

100

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years
  • ECOG performance status less than 2
  • Histological confirmation of classical Hodgkin lymphoma
  • At least two prior lines of antitumor therapy
  • Ineligible for or refused transplant
  • Life expectancy of at least 3 months
  • At least one measurable lymphoma lesion larger than 1 cm
  • Completed previous treatment more than 4 weeks prior with recovery to grade 1 toxicity or less
  • If previously had autologous hematopoietic stem-cell transplantation, it was more than 3 months ago
  • Adequate marrow, liver, kidney, and heart function
Not Eligible

You will not qualify if you...

  • Prior treatment with the combination of Chidamide+Decitabine and anti-PD-1 antibody or Brentuximab Vedotin plus anti-PD-1 antibody
  • Any autoimmune disease or history requiring corticosteroids or immunosuppressive drugs
  • Serious uncontrolled medical disorders or active infections, especially pulmonary infection
  • Active or recent (within 1 month) alimentary tract hemorrhage
  • Prior organ transplant
  • Pregnant or breastfeeding women
  • Positive pregnancy test at enrollment or before treatment
  • Compulsory detention for psychiatric or physical illness

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital

Beijing, China, 100853

Actively Recruiting

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Research Team

H

Han wei dong

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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