A Study of Chidamide With AZA in MRD Positive AML After Transplant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: chidamide and azacitidine.
- Who it may be relevant to
- Registry conditions: AML, Adult, Minimal Residual Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
acute myeloid leukemia (AML) is a malignant tumor of the hematopoietic system with high heterogeneity in cytogenetics and molecular biology.Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is still the primary treatment option for patients with AML and the most effective method for radical treatment of AML.Despite considerable progress in allo-HSCT over the past decade, 30%-40% of patients still relapse, and post-transplant relapse remains the leading cause of death in patients with AML.
Detailed description
Investigators proposed Chidamide combined with azacitidine as the prospective treatment for MRD-positive AML patients before and after transplantation, hoping to reduce the recurrence rate of transplantation and improve the transplantation effect. The efficacy and safety of the method will be verified by this clinical study.
Interventions
- Drug chidamide and azacitidine
chidamide：10mg orally,day 1 to day 6 every week, Take it for two weeks, rest for two weeks,so 28 days for a circle, 12 circles totally. azacitidine:50mg,subcutaneous injection,day 1 to day 5 every week, 28 days for a circle, 6 circles totally.
Primary outcome measures
- the rate of RFS in 6 months [Time frame: 6 months]
Secondary outcome measures (6)
- the rate of MRD turn negative in 6 months [Time frame: 6 months]
- the time length of MRD negative [Time frame: 24 months]
- the 1 year/2 year RFS [Time frame: 24 months]
- the 1 year/2 year OS [Time frame: 24 months]
- the rate of GVHD [Time frame: 24 months]
- Incidence of Treatment-Emergent Adverse Events [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- Patients diagnosed with AML (diagnostic criteria refer to WHO2016 criteria, except M3) can detect small residual lesions (MRD) positive after allogeneic hematopoietic stem cell transplantation (allo-HSCT);
- ≥18 years old;
- ECOG≤3;
- lifespan≥3 months;
- Take contraceptive measures;
- Sign informed consent.
Exclusion criteria
- Allergic to the study drug;
- A gastrointestinal condition that prevents oral medication;
- active infection;
- Dysfunction of vital organs;
- other malignancies;
- HIV infection;
- HBV or HCV;
- The QT interval is prolonged;
- Pregnant or lactating women;
- Is participating in other clinical studies;
- The researchers did not consider it appropriate to participate in this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Guangdong Provincial People's Hospital — Guangzhou
Publications
- Ling W, Wu P, Wu S, Luo C, Huang L, Chen X, Liang X, Li Z, Xu R, Tan J, Wang J, Lai P, Du X, Weng J. MRD-driven HDACi-based therapy post-transplant: a real-world study in high-risk acute myeloid leukemia. Ann Hematol. 2026 Jul 13. doi: 10.1007/s00277-026-07117-7. Online ahead of print. PMID 42439986
Identifiers
NCT: NCT06066905 · Chidaza101