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

Xuejie Jiang

Status and phase: Enrolling; Phase 2

Conditions: Leukemia, Myeloid

Treatments: Drug: Decitabine and Ara-C; Drug: Ara-C

Study type: Interventional

Funder types: Other

Identifiers

NCT03417427

LC2016YM005

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 14 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Decitabine and Ara-C

Active Comparator group

Description:

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.

Treatment:

Drug: Decitabine and Ara-C

Ara-C

Placebo Comparator group

Description:

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.

Treatment:

Drug: Ara-C