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

Sponsor
Xuejie Jiang (Other)
Overall Status
Recruiting
CT.gov ID
NCT03417427
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
84
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Feb 1, 2018
Anticipated Primary Completion Date :
Jan 31, 2022
Anticipated Study Completion Date :
Jan 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Drug: 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.
Other Names:
  • Decitabine in combination with high-dose of Ara-C

    		•
    Placebo Comparator: 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.

    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.
    Other Names:
  • High-dose of Ara-C

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Minimal residual disease [1 month]

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

    Secondary Outcome Measures

    1. Overall survival [3 months]

      AML patients are followed up every 3 months to evaluate overall survival

    2. Relapse free survival [3 months]

      AML patients are followed up every 3 months to evaluate relapse free survival.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 60 Years
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nanfang Hospital of Southern Medical University Guanzhou Guangdong China 510515

    Sponsors and Collaborators

    • Xuejie Jiang

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xuejie Jiang, Associate Professor, Nanfang Hospital of Southern Medical University
    ClinicalTrials.gov Identifier:
    NCT03417427
    Other Study ID Numbers:
    • LC2016YM005
    First Posted:
    Jan 31, 2018
    Last Update Posted:
    Apr 27, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Xuejie Jiang, Associate Professor, Nanfang Hospital of Southern Medical University
    acute myeloid leukemia
    Intermediate-risk
    demethylation drug
    complete remission
    Additional relevant MeSH terms:
    Leukemia, Myeloid
    Cytarabine
    Decitabine

    Study Results

    No Results Posted as of Apr 27, 2020