Clinical trial · Observational
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
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Maintenance Therapy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Study group
- description
- Use of chidamide-based regimens as maintenance therapy for at least 3 months after the initiation of the maintenance therapy, with chidamide as a dose of 10 mg/day, days 1-14, a 28-day cycle, for at least 6 months. Besides chidamide, the combining agents were record.
Primary outcomes (1)
- measure
- MRD negativity rate
- timeFrame
- After 6 cycles of 28-day maintenance therapy, an average of 6 months
- description
- MRD negativity rate after 6 cycles of maintenance therapy (28 days for one cycle).
Secondary outcomes (4)
- measure
- Duration of remission, DoR
- timeFrame
- Through study completion, an average of 1 year
- description
- The time from the initiation of maintenance therapy to disease relapse or the last follow-up.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age range ≥18 years, both male and female were eligible. 2. Patients with CFB-AML and MRD positive, or patients with ELN 2022-high risk fusion genes, such as MLL rearrangement, or NUP98 rearrangement, ect. 3. Use of chidamide-based regimens as maintenance therapy for at least 3 months, without undergoing or not planning to undergo allo-HSCT. 4. ECOG ≤4; 5. 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). Exclusion Criteria: 1. Known history of allergy to the study drug. 2. Resistant to chidamide. 3. Unable to take oral medications. 4. Concurrent uncontrolled active infection (including bacterial, fungal, or viral infections). 5. Concurrent uncontrolled major organ failure. 6. Currently participating in other clinical studies that affected the primary objectives of this study. 7. Patients deemed by the investigators to be unsuitable for participation in this study.
References
Publications (0)
Data not yet available