RecruitingPhase 1Phase 2NCT05270200

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

To Evaluate Safety and Efficiency of AZA Combined With Chidamide as Maintenance Therapy in High-risk Acute Myeloid Leukemia Patients After Allogeneic Hematopoietic Stem Cell Transplantation:A Multicenter, Single-arm Study


Sponsor

Zhujiang Hospital

Enrollment

20 participants

Start Date

Feb 1, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a combination of two drugs — azacitidine and chidamide — given after a stem cell transplant can prevent acute myeloid leukemia (AML) from coming back. **You may be eligible if...** - You are 18–60 years old with a diagnosis of AML (not a specific subtype called M3) - Your AML has poor genetic features, did not respond to initial treatment, relapsed, or developed from another blood condition - You have recently had a stem cell transplant - Your performance status is adequate (ECOG 0–3) - Your expected survival is at least 3 months - Your blood counts and liver function meet required thresholds **You may NOT be eligible if...** - You have the M3 subtype of AML (acute promyelocytic leukemia) - You have significant transplant-related complications above Grade 2 - Your liver, kidney, or blood counts are too low - Your expected survival is less than 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAzacitidine

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

DRUGChidamide

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


Locations(1)

Nanfang Hospital of Southern Medical University

Guanzhou, Guandong, China

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NCT05270200


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