MRD-directed Therapy for Low-risk and Intermediate-risk AML.
Primary Purpose
Acute Myeloid Leukemia, Minimal Residual Disease
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
MRD-directed therapy
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring MRD, Acute myeloid leukemia
Eligibility Criteria
Inclusion Criteria:
Low-risk and intermediate-risk AML Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion Criteria:
Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) Patients with any conditions not suitable for the trial (investigators' decision)
Sites / Locations
- Nanfang Hospital, Southern Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MRD-directed therapy
Arm Description
Outcomes
Primary Outcome Measures
disease-free survival (DFS)
Secondary Outcome Measures
leukemia relapse rate
disease-free survival (DFS)
overall survival (OS)
Full Information
NCT ID
NCT02870777
First Posted
August 14, 2016
Last Updated
March 2, 2020
Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Guangzhou First People's Hospital, Zhujiang Hospital, Peking University People's Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT02870777
Brief Title
MRD-directed Therapy for Low-risk and Intermediate-risk AML.
Official Title
Minimal Residual Disease-directed Therapy for Low-risk and Intermediate-risk Acute Myeloid Leukemia.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Guangzhou First People's Hospital, Zhujiang Hospital, Peking University People's Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Acute myeloid leukemia(AML) patients with favorable and intermediate cytogenetics at diagnosis are generally excluded from first-line allo-SCT. However, these patients may eventually relapse in some cases. Our previous study found that stratification of treatment based on cytogenetics and therapeutic response could benefit low and intermediate AML. To further verify the results, we conducted a prospective multi-center study. The purpose of this study is to establish risk stratification based on cytogenetics and minimal-residual-disease (MRD) analysis to determine whether a MRD-directed therapy for low and intermediate AML patients has positive results in terms of overall survival.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Minimal Residual Disease
Keywords
MRD, Acute myeloid leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Model Description
MRD-directed therapy
Masking
None (Open Label)
Allocation
N/A
Enrollment
743 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRD-directed therapy
Arm Type
Experimental
Intervention Type
Combination Product
Intervention Name(s)
MRD-directed therapy
Intervention Description
The purpose of this study is to establish risk stratification based on cytogenetics at diagnosis and MRD analysis after induction chemotherapy and before consolidation chemotherapy to determine whether a MRD directed therapy for low and intermediate AML patients has positive results in terms of overall survival.
Primary Outcome Measure Information:
Title
disease-free survival (DFS)
Time Frame
3 year
Secondary Outcome Measure Information:
Title
leukemia relapse rate
Time Frame
3 year
Title
disease-free survival (DFS)
Time Frame
3 year
Title
overall survival (OS)
Time Frame
3 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Low-risk and intermediate-risk AML Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion Criteria:
Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) Patients with any conditions not suitable for the trial (investigators' decision)
Facility Information:
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
MRD-directed Therapy for Low-risk and Intermediate-risk AML.
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