Chidamide in HR-AML

NCT07822789 | Active Not Recruiting

• 1 other identifier: GD2H-2026-482
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Acute Myeloid Leukemia; Maintenance Therapy

Keywords

Acute myeloid leukemia; Chidamide; Maintenance therapy; Real-world Study

Outcome Measures

Primary Outcomes (1)

• MRD negativity rate

  MRD negativity rate after 6 cycles of maintenance therapy (28 days for one cycle).

  After 6 cycles of 28-day maintenance therapy, an average of 6 months

Secondary Outcomes (4)

• Duration of remission, DoR

  Through study completion, an average of 1 year

• Relapsed-free survival

  Through study completion, an average of 1 year

• Overall survival

  Through study completion, an average of 1 year

• Adverse events

  Through study completion, an average of 1 year

Study Arms (1)

Study group

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

High-risk patients who had completed standard induction and consolidation therapy and achieved complete remission (CR) or CR with incomplete peripheral blood count recovery (CRi), and could not receive allo-HSCT, and had taken chidamide as maintenance therapy for at least 3 months. High-risk patients were defined as those with CFB-AML and MRD positive, or patients with ELN 2022-high risk fusion genes, such as MLL rearrangement, or NUP98 rearrangement, ect.

You may qualify if:

• 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).

You may not qualify if:

• Known history of allergy to the study drug.
• Resistant to chidamide.
• Unable to take oral medications.
• Concurrent uncontrolled active infection (including bacterial, fungal, or viral infections).
• Concurrent uncontrolled major organ failure.
• 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.

Sponsors & Collaborators

• Guangdong Second Provincial General Hospital: lead
• Nanfang Hospital, Southern Medical University: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator
• Guangzhou First People's Hospital: collaborator
• Dongguan People's Hospital: collaborator
• Zhongshan People's Hospital, Guangdong, China: collaborator
• Shunde Hospital, Sothen Medical University: collaborator
• Shenzhen Second People's Hospital: collaborator

Study Sites (1)

Department of Hematology, Guangdong Second Provincial General Hospital

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 16, 2026
• Study Start: July 27, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)