A Study of Chidamide With AZA in MRD Positive AML After Transplant

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Study of Chidamide With AZA in MRD Positive AML After Transplant

Conditions
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AML, Adult, Minimal Residual Disease

Intervention / Treatment
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* Drug: chidamide and azacitidine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chidamide and azacitidine<br> | Drug: chidamide and azacitidine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of RFS in 6 months | relapse-free survival | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of MRD turn negative in 6 months | minimal residual disease turn negative | 6 months | 
| the time length of MRD negative | minimal residual disease negative | 24 months | 
| the 1 year/2 year RFS | relapse-free survival | 24 months | 
| the 1 year/2 year OS | overall survival | 24 months | 
| the rate of GVHD | graft-versus-host disease | 24 months | 
| Incidence of Treatment-Emergent Adverse Events | Grade 1 to Grade 4 ,according to Common Terminology Criteria for Adverse Events, versions 5.0 | 24 months |