A Clinical Trail of Demethylation Drug Combined With Chemotherapy in Intermediate-risk AML

Study Overview
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Brief Summary
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It is often impossible to find therapeutic target in intermediate-risk AML, so it is very important to select appropriate chemotherapy protocol to eliminate minimal residual disease (MRD) in these AML patients. Recent studies demonstrated that leukemia microenvironment is the shelter nich for leukemia stem cells and the essential reason for impossibly eliminating MRD. Demethylation drug not only prove the effect of chemotherapy, but also change leukemia microenvironment through epigenetics modification. Both of them will result in eliminating MRD in patients with AML. The investigators designed a multicenter randomized control clinical trail to evaluate the effect of demethylation drug combined with chemotherapy in AML patients with intermediate-risk factors after hematological complete remission. Efficacy will be evaluated through MRD detected by flow cytometry every 1 month. Continuous negative MRD indicates a good prognosis. The patients with continuous negative MRD can select auto-HSCT or consolidation chemotherapy, those with continuous positive MRD should be considered as candidates of allo-HSCT. Overall survival and relapse free survival will be recorded after follow-up every 3 months. It will provide a basis for precision therapy and a new way for designing a novel protocol for intermediate-risk AML. This clinical trail will benefit to the AML patients with intermediate-risk factors.

Official Title
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A Multicenter Randomized Control Clinical Trail of Evaluating Effect of Demethylation Drug Combined With Chemotherapy in Patients With Intermediate-risk AML After Hematological Complete Remission

Conditions
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Leukemia, Myeloid

Intervention / Treatment
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* Drug: Decitabine and Ara-C
* Drug: Ara-C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AML patients with normal heart, lung, liver and renal function, or without serious infection. ECOG score is below 2 Exclusion Criteria: AML patients with abnormal heart, lung, liver and renal function, or with serious infection. ECOG score is over 2

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 60 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Decitabine and Ara-C<br>Intermediate-risk AML patients with hematological complete remission and positive minimal residual disease (MRD) will receive decitabine (15mg/m2 d1-5) combined with high-dose of Ara-C (2g/m2 d4-6) consolidation chemotherapy. | Drug: Decitabine and Ara-C<br>* Decitabine in combination with high-dose of Ara-C is used to improve the effect of consolidation chemotherapy. It is expected to make minimal residual disease (MRD) become negative in more patients with intermediate-risk AML.<br>* Other names: Decitabine in combination with high-dose of Ara-C;|
| Placebo Comparator: Ara-C<br>Intermediate-risk AML patients with hematological complete remission and positive minimal residual disease (MRD) will receive high-dose of Ara-C (2g/m2 d4-6) consolidation chemotherapy. | Drug: Ara-C<br>* Intermediate-risk AML patients with hematological complete remission and positive minimal residual disease (MRD) will receive high-dose of Ara-C (2g/m2 d4-6) consolidation chemotherapy.<br>* Other names: High-dose of Ara-C;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal residual disease | Minimal residual disease is detected by flow cytometry every 1 month in AML patients. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | AML patients are followed up every 3 months to evaluate overall survival | 3 months | 
| Relapse free survival | AML patients are followed up every 3 months to evaluate relapse free survival. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute myeloid leukemia, Intermediate-risk, demethylation drug, complete remission