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

Phase 2

Recruiting

• Conditions: Leukemia, Myeloid
• Interventions: Drug: Decitabine and Ara-C; Drug: Ara-C

• Registration Number: NCT03417427
• Lead Sponsor: Xuejie Jiang

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-13
• Study First Submitted QC: 2018-01-30
• Study First Posted: 2018-01-31
• Study Start: 2018-02-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-24
• Last Update Posted: 2020-04-27
• Primary Completion: 2022-01-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Decitabine and Ara-C	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.
Ara-C	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.

Primary Outcome Measures

Name	Time	Method
Minimal residual disease	1 month	Minimal residual disease is detected by flow cytometry every 1 month in AML patients.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Nanfang Hospital of Southern Medical University; 🇨🇳 Guanzhou, Guangdong, China