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Clinical Trials/NCT03417427
NCT03417427RecruitingPhase 2

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

Xuejie Jiang1 site in 1 country100 target enrollmentStarted: February 1, 2018Last updated:
Conditions
Interventions
Drugs

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

Placebo Comparator

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

Active Comparator

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

Sponsor
Xuejie Jiang
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Xuejie Jiang

Associate Professor

Nanfang Hospital, Southern Medical University

Study Sites (1)

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