Leukemia, Myeloid
Conditions
Keywords
acute myeloid leukemia, Intermediate-risk, demethylation drug, complete remission
Brief summary
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.
Interventions
DRUGDecitabine and Ara-C
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.
DRUGAra-C
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.
Sponsors
Xuejie Jiang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
14 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minimal residual disease | 1 month | Minimal residual disease is detected by flow cytometry every 1 month in AML patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 3 months | AML patients are followed up every 3 months to evaluate overall survival |
| Relapse free survival | 3 months | AML patients are followed up every 3 months to evaluate relapse free survival. |
Countries
China
Contacts
Primary ContactXuejie Jiang, Doctor
Outcome results
None listed