- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03417427
A Clinical Trail of Demethylation Drug Combined With Chemotherapy in Intermediate-risk AML
April 24, 2020 updated by: Xuejie Jiang
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
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xuejie Jiang, doctor
- Phone Number: +8618688869522
- Email: jxj3331233@163.com
Study Locations
-
-
Guangdong
-
Guanzhou, Guangdong, China, 510515
- Recruiting
- Nanfang Hospital of Southern Medical University
-
Contact:
- Xuejie Jiang, doctor
- Phone Number: +8618688869522
- Email: jxj3331233@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 60 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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:
|
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Minimal residual disease
Time Frame: 1 month
|
Minimal residual disease is detected by flow cytometry every 1 month in AML patients.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 3 months
|
AML patients are followed up every 3 months to evaluate overall survival
|
3 months
|
Relapse free survival
Time Frame: 3 months
|
AML patients are followed up every 3 months to evaluate relapse free survival.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2018
Primary Completion (Anticipated)
January 31, 2022
Study Completion (Anticipated)
January 31, 2025
Study Registration Dates
First Submitted
May 13, 2017
First Submitted That Met QC Criteria
January 30, 2018
First Posted (Actual)
January 31, 2018
Study Record Updates
Last Update Posted (Actual)
April 27, 2020
Last Update Submitted That Met QC Criteria
April 24, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Leukemia
- Leukemia, Myeloid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Decitabine
- Cytarabine
Other Study ID Numbers
- LC2016YM005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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