NCT07822789Active, not recruiting
Chidamide in HR-AML
Efficacy and Safety of Chidamide in the Maintenance Therapy of High-Risk Acute Myeloid Leukemia Patients: A Multi-center Real-World Study
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
Acute myeloid leukemia (AML) patients with fusion gene-positive including core binding factor (CBF), mixed-lineage leukemia (MLL) gene rearrangement have a high incidence of relapse if they have continuously positive measurable residual disease (MRD) or ELN 2022-high risk chromosome abnormality and could not be bridged to allogenetic heamatopoitic stem cell transplantation (allo-HSCT). Histone deacetylase (HDAC) is known to abnormally recruit in these fusion gene-positive AML, and has been proven to be a promising therapy target. Whether HDAC inhibitor chidamide could be used as a maintenance therapy in these AML patients remains unknown. This study aims to evaluate the efficacy and safety of chidamide in the maintenance therapy of high-risk acute myeloid leukemia (AML) patients with core binding factor (CBF) and measurable residual disease (MRD) positivity, or ELN 2022-high risk fusion gene positive.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 33 (actual)
- First submitted
- 4 Sept 2026
- Start date
- 27 Jul 2026
- Primary completion date
- 1 Aug 2026
- Lead sponsor
- Guangdong Second Provincial General Hospital
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT07822789
What you commit to
- Study type: Observational
- Participants enrolled: 33
- From 27 Jul 2026 to the primary completion date, 1 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unable to take oral medications.
- Concurrent uncontrolled active infection (including bacterial, fungal, or viral infections).
- Concurrent uncontrolled major organ failure.
Other illness
- Known history of allergy to the study drug.
Other
- Resistant to chidamide.
- Currently participating in other clinical studies that affected the primary objectives of this study.
- Patients deemed by the investigators to be unsuitable for participation in this study.
Who the study is looking for
- Age range ≥18 years, both male and female were eligible.
- Patients with CFB-AML and MRD positive, or patients with ELN 2022-high risk fusion genes, such as MLL rearrangement, or NUP98 rearrangement, ect.
- Use of chidamide-based regimens as maintenance therapy for at least 3 months, without undergoing or not planning to undergo allo-HSCT.
- ECOG ≤4;
- At screening, laboratory tests meet the following criteria: (1) Complete blood count: hemoglobin (Hb) ≥90 g/L, absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet count (PLT) ≥90×10⁹/L; (2) Biochemical tests: serum creatinine (Cr) ≤1.5× upper limit of normal (ULN); total bilirubin (TBIL) ≤1.5×ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (for cases with liver metastasis: ≤5×ULN).
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Hematology, Guangdong Second Provincial General Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.