Tests chidamide to help prevent acute myeloid leukemia from returning after stem cell transplant
Tests a pill, chidamide, after stem cell transplant in adults with high-risk acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Chidamide Prevents Recurrence of High-risk AML After Allo-HSCT
Key facts
- Where
- Chengdu, ChinaSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 65 with high-risk acute myeloid leukemia who have had a donor stem-cell transplant and are in complete remission. They would take chidamide by mouth to help prevent relapse.
- Age
- 18 to 65 years
- Sex
- All sexes can join.
- Disease stage
- High-risk acute myeloid leukemia, in complete remission after a donor stem-cell transplant (allo-HSCT). Blood counts must have recovered. No central nervous system involvement after the transplant.
- Earlier treatment
- Must have had an allogeneic stem-cell transplant (allo-HSCT).
Main reasons for not taking part
- Active GVHD (graft-versus-host disease)
- Poor graft function after the transplant
- Uncontrolled active infection
- Known HIV infection or AIDS, or active hepatitis B or C
- Pregnant or breastfeeding women
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT05682755, who can take part
Where in China
- West China Hospital of Sichuan UniversityChengdu, ChinaContact: Jie Ji, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Sichuan University
- Trial code
- NCT05682755
- Record updated
- 12 January 2023
- Original description
The goal of this phase I/II clinical trial is to test in high-risk acute myeloid leukemia (AML) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is:Read full original descriptionShow less
Chidamide Prevents the Recurrence of High-risk Acute Myeloid Leukemia After Allogeneic Hematopoietic Stem-cell Transplantation: A Prospective, Single-centered, Single-arm, Phase I/II Clinical Study
The goal of this phase I/II clinical trial is to test in high-risk acute myeloid leukemia (AML) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is:
• The efficacy and safety of chidamide maintenance therapy in reducing the recurrence rate and GVHD incidence in high-risk AML patients after allo-HSCT.
Participants will take oral chidamide (Epidaza) until 180 days after allo-HSCT.
Inclusion: Age ≥ 18 years old and ≤ 65 years old when signing the Informed Consent Form (ICF); KPS score > 60 or ECOG score 0-2; The expected survival period > 3 months; Received allo-HSCT and achieved complete remission (CR); Reach the standard of hematopoietic reconstitution (neutrophil count ≥ 0.5×10\^9/L for 3 consecutive days without G-CSF application, platelet count ≥ 20×10\^9/L for 7 consecutive days without platelet transfusion, Hb ≥ 80 g /L without red blood cell transfusion); and neutrophil count ≥ 1.5×10\^9/L, platelet count ≥ 50×10\^9/L within 45 days after transplantation; No central nervous system involvement or clinical symptoms after transplantation; Those who have no serious functional damage to important organs of the body; Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures; Females of childbearing age must afford a serum pregnancy test within 7 days before the first dose, and the result should be negative; female participants and their partners should agree to use effective contraception from signing the ICF until 6 months after the last dose.
Exclusion: Participating in other clinical studies, or planning to start treatment in this study and less than 4 weeks before the end of treatment in the previous clinical study; Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc; Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective; Combined with other malignant tumors and require treatment; Have a history of allergy to Chidamide; Patients with known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome; Patients with active chronic hepatitis B or active hepatitis C; History of prolonged QT syndrome; Poor graft function (PGF) occurred after allo-HSCT; Active GVHD; Pregnant or lactating females; Patients considered by other researchers to be unsuitable for this study.