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

NCT05270200 | Recruiting Phase 1

• 1 other identifier: AZA+Chidamide
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Leukemia, Myeloid, Acute

Keywords

Acute myelogenous leukemia; Allogenetic stem cell transplant; Maintenance therapy; Azacitidine; Chidamide; High-risk AML

Outcome Measures

Primary Outcomes (2)

• Number of Paticipants With Adverse Events as a Measure of Safety

  Safety were measured with respect to: 1. Safety measurements 2. Incidence of adverse events

  From the day of stem cell transplantation to one year after stem cell transplantation

• One year cumulative incidence of relapse

  Leukemia relapse base on morphoogy criterion

  From the day of stem cell transplantation to one year after stem cell transplantation

Secondary Outcomes (3)

• Relapes-free Survival（RFS）

  From the day of stem cell transplantation to one year after stem cell transplantation

• Overall survival（OS）

  From the day of stem cell transplantation to one year after stem cell transplantation

• The cumulative Incidence rate of GVHD

  From the day of stem cell transplantation to one year after stem cell transplantation

Other Outcomes (1)

• Single-cell sequencing

  Before the maintenance therapy and before the 7 cycles of maintenance

Study Arms (1)

Azacitidine combined with Chidamide

EXPERIMENTAL

Patients will recieve six courses of azacitidine 50mg/m2 through a needle under your skin on Days 1-3.Each course is 28 days long.At the same time patients will recieve oral chidamide 5mg per day for no more than 2 years.

Drug: Azacitidine; Drug: Chidamide

Interventions

Azacitidine DRUG

Patients will recieve six courses of azacitidine 50mg/m2 through a needle under skin on Days 1-3.Each course is 28 days long.

Also known as: 5-Azacitidine, 5-aza, Vidaza, 5-AZC

Azacitidine combined with Chidamide

Chidamide DRUG

Patients will recieve oral chidamide 5mg per day for no more than 2 years.

Also known as: Epidaza

Azacitidine combined with Chidamide

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 60 years old,both male and female
• Be able to understand and sign informed consent
• Patients with a diagnosis of AML not M3 according to the 2016 World Health Organization (WHO) Acute Myeloid Leukemia Classification and Diagnostic
• Patients have AML with poor genetic abnormalities,primary refractory AML,relapsed AML or secondary AML
• Patients with an ECOG performance status 0,1,2 or 3
• Expected survival time ≥ 3 months
• Non-hematological toxicity related to transplantation does not exceed Grade 2
• Laboratory indicators meet the following standards:
• days before the first day of the first course of treatment, bilirubin, ALT and AST were all less than 3 times the upper limit of normal.
• Measure twice within 7 days before the first day of the first course of treatment, at least 2 days apart, the neutrophil count are greater than 1.5×10/L and without G-CSF treatment.
• Measure twice within 7 days before the first day of the first course of treatment, at least 2 days apart, platelet count greater than 80×10/L and without platelet transfusion.
• Serum creatinine clearance rate is greater than 30ml/min.

You may not qualify if:

• Uncontrollable active infection
• Patients with active hepatitis B or C or HIV infection before enrollment
• Have a grade III-IV graft-versus-host disease

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Nanfang Hospital of Southern Medical University

Guanzhou, Guandong, 510250, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Azacitidine; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Rui Huang, Doctor

  Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rui Huang, Doctor

CONTACT

+8615918528317; Rachelchn@163.com

Yunqing Wang, Bachelor

CONTACT

+8618585509970; Wangyun7q@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: March 8, 2022
• Study Start: February 1, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available and permanently disclosed within 6 months after the trial.
• Access Criteria: You can log in to the website for data access or contact us for data.

Locations

CN (1)