Risk-stratified Therapy Based on Molecular Cytogenetic Aberration and Treatment Response in AML
NCT03620955 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000
Last updated 2019-11-04
Summary
Risk-stratified therapy based on molecular and cytogenetic for acute myeloid leukemia (AML) is well accepted and benefits patients' survival. However, neither every patient with low risk factors obtains better survival, nor all high risk patients experience worse outcome. Lots of data have shown that the early treatment response presenting as minimal residual disease (MRD) has an important role in prognostic prediction. In this study, we perform risk stratification based on not only Cytogenetic and Molecular characteristic, but also MRD after three courses of chemo therapy in AML cohort. Patients with MRD positive would be moved to a higher risk class. And then the risk-stratified therapy should be considered according to the new risk stratification.
Conditions
- Risk-directed Therapy
- Cytogenetic Abnormality
- Molecular Abnormality
- MRD
Interventions
- OTHER
-
Justified risk stratification based on MRD after three course chemo therapy
All patients are routinely divided into different risk groups according to the NCCN guild based on cytogenetic and molecular abnormality. Then all patients are treated with anthracycline combined with cytarabine regimens for two courses . The patients without obtaining CR will go on one cycle of salvage therapy and then be bridged to allo-HSCT. Those acquiring CR will be given one more course of HDAC as consolidation treatment and then be detested MRD with flow cytometry after that. The patients with MRD positive would be moved to a higher risk class.The stratified therapy should be considered according to the new risk stratification.
Sponsors & Collaborators
-
Second Affiliated Hospital, Sun Yat-Sen University
collaborator OTHER -
Third Affiliated Hospital, Sun Yat-Sen University
collaborator OTHER -
Guangzhou First People's Hospital
collaborator OTHER -
Wuhan General Hospital of Guangzhou Military Command
collaborator OTHER -
Shenzhen Hospital of Southern Medical University
collaborator OTHER -
Peking University Shenzhen Hospital
collaborator OTHER -
Shenzhen Second People's Hospital
collaborator OTHER -
Zhongshan People's Hospital, Guangdong, China
collaborator OTHER -
First Affiliated Hospital of Guangxi Medical University
collaborator OTHER -
Xiangya Hospital of Central South University
collaborator OTHER -
The Third Xiangya Hospital of Central South University
collaborator OTHER -
First Affiliated Hospital of Gannan Medical University
collaborator OTHER -
Peking University People's Hospital
collaborator OTHER -
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
collaborator OTHER -
The First Affiliated Hospital of Zhengzhou University
collaborator OTHER -
Chenzhou NO. 1 people's Hospital
collaborator UNKNOWN -
Nanfang Hospital, Southern Medical University
lead OTHER
Principal Investigators
-
Qifa Liu · Nanfang Hospital, Southern Medical University
Eligibility
- Min Age
- 14 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-08-10
- Primary Completion
- 2020-12-31
- Completion
- 2021-12-31
Countries
- China
Study Locations
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