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
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Minimal residual disease
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 14 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Ara-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.
Intervention: Ara-C (Drug)
Decitabine and Ara-C
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.
Intervention: Decitabine and Ara-C (Drug)
Outcomes
Primary Outcomes
Minimal residual disease
Time Frame: 1 month
Minimal residual disease is detected by flow cytometry every 1 month in AML patients.
Secondary Outcomes
- Overall survival(3 months)
- Relapse free survival(3 months)
Investigators
Xuejie Jiang
Associate Professor
Nanfang Hospital, Southern Medical University
