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

NCT ID: NCT03417427

Last Updated: 2020-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2025-01-31

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.

Conditions

Leukemia, Myeloid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Decitabine and Ara-C

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

Ara-C

Intervention Type: DRUG

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.

Interventions

Decitabine 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.

Intervention Type: DRUG

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 Type: DRUG

Other Intervention Names

Decitabine in combination with high-dose of Ara-C; High-dose of Ara-C

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuejie Jiang

OTHER

Sponsor Role: lead

Responsible Party

Xuejie Jiang

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Nanfang Hospital of Southern Medical University

Guanzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xuejie Jiang, Doctor

Role: CONTACT

jxj3331233@163.com

+8618688869522

Facility Contacts

Xuejie Jiang, doctor

Role: primary

jxj3331233@163.com

+8618688869522

Other Identifiers

LC2016YM005

Identifier Type: -

Identifier Source: org_study_id