Back to resultsA Clinical Trail of Demethylation Drug Combined With Chemotherapy in Intermediate-risk AML
Primary Purpose
Leukemia, Myeloid
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Decitabine and Ara-C
Ara-C
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Myeloid focused on measuring acute myeloid leukemia, Intermediate-risk, demethylation drug, complete remission
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
Sites / Locations
- Nanfang Hospital of Southern Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Decitabine and Ara-C
Ara-C
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Minimal residual disease
Minimal residual disease is detected by flow cytometry every 1 month in AML patients.
Secondary Outcome Measures
Overall survival
AML patients are followed up every 3 months to evaluate overall survival
Relapse free survival
AML patients are followed up every 3 months to evaluate relapse free survival.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03417427
Brief Title
A Clinical Trail of Demethylation Drug Combined With Chemotherapy in Intermediate-risk AML
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
January 31, 2022 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xuejie Jiang
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid
Keywords
acute myeloid leukemia, Intermediate-risk, demethylation drug, complete remission
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Decitabine and Ara-C
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Ara-C
Arm Type
Placebo Comparator
Arm Description
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
Intervention Name(s)
Decitabine and Ara-C
Other Intervention Name(s)
Decitabine in combination with high-dose of Ara-C
Intervention Description
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
Intervention Name(s)
Ara-C
Other Intervention Name(s)
High-dose of Ara-C
Intervention Description
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 Measure Information:
Title
Minimal residual disease
Description
Minimal residual disease is detected by flow cytometry every 1 month in AML patients.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Overall survival
Description
AML patients are followed up every 3 months to evaluate overall survival
Time Frame
3 months
Title
Relapse free survival
Description
AML patients are followed up every 3 months to evaluate relapse free survival.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuejie Jiang, Doctor
Phone
+8618688869522
Email
jxj3331233@163.com
Facility Information:
Facility Name
Nanfang Hospital of Southern Medical University
City
Guanzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuejie Jiang, doctor
Phone
+8618688869522
Email
jxj3331233@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Clinical Trail of Demethylation Drug Combined With Chemotherapy in Intermediate-risk AML
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