MRD-directed Therapy for Low-risk and Intermediate-risk AML.
- Conditions
- Acute Myeloid LeukemiaMinimal Residual Disease
- Interventions
- Combination Product: MRD-directed therapy
- Registration Number
- NCT02870777
- Lead Sponsor
- Nanfang Hospital, Southern Medical University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 743
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.
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MRD-directed therapy MRD-directed therapy -
- Primary Outcome Measures
Name Time Method disease-free survival (DFS) 3 year
- Secondary Outcome Measures
Name Time Method leukemia relapse rate 3 year overall survival (OS) 3 year disease-free survival (DFS) 3 year
Trial Locations
- Locations (1)
Nanfang Hospital, Southern Medical University
🇨🇳Guangzhou, Guangdong, China