Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 60Years
All Genders
NCT05270200

Single Arm Study of Post-transplant Azacitidine and Chidamide for Prevention of Acute Myelogenous Leukemia Relapse

Led by Zhujiang Hospital · Updated on 2025-09-25

20

Participants Needed

1

Research Sites

308 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical research study is to learn if azacitidine combined with Chidamide will help to control the disease in patients with high-risk AML after an allogeneic stem cell transplant. The safety of this combination will also be studied.

CONDITIONS

Official Title

Single Arm Study of Post-transplant Azacitidine and Chidamide for Prevention of Acute Myelogenous Leukemia Relapse

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 60 years old, both male and female
  • Able to understand and sign informed consent
  • Diagnosed with AML not M3 according to the 2016 WHO AML Classification
  • Have AML with poor genetic abnormalities, primary refractory AML, relapsed AML, or secondary AML
  • ECOG performance status of 0, 1, 2, or 3
  • Expected survival time of 3 months or longer
  • Non-hematological toxicity related to transplantation does not exceed Grade 2
  • Laboratory requirements before treatment start:
  • Bilirubin, ALT, and AST less than 3 times the upper limit of normal
  • Neutrophil count greater than 1.5 x 10^9/L without G-CSF treatment, measured twice at least 2 days apart within 7 days before treatment
  • Platelet count greater than 80 x 10^9/L without platelet transfusion, measured twice at least 2 days apart within 7 days before treatment
  • Serum creatinine clearance rate greater than 30 ml/min
Not Eligible

You will not qualify if you...

  • Uncontrollable active infection
  • Active hepatitis B, hepatitis C, or HIV infection before enrollment
  • Grade III-IV graft-versus-host disease

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

Nanfang Hospital of Southern Medical University

Guanzhou, Guandong, China, 510250

Actively Recruiting

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Research Team

R

Rui Huang, Doctor

CONTACT

Y

Yunqing Wang, Bachelor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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