MRD Clinical Trial
Official title:
Risk-stratified Therapy Based on Molecular and Cytogenetic Aberration and Treatment Response in Acute Myeloid Leukemia
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.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | December 2021 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 60 Years |
Eligibility |
Inclusion Criteria: All newly diagnosed AML exclusively of APL with age range from 14 to 60-year old Exclusion Criteria: Any abnormality in a vital sign (e.g., organ function failure, serious infection ) Patients with any conditions not suitable for the trial (investigators' decision) |
Country | Name | City | State |
---|---|---|---|
China | Department of Hematology,Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Nanfang Hospital of Southern Medical University | Chenzhou NO. 1 people's Hospital, First Affiliated Hospital of Gannan Medical University, First Affiliated Hospital of Guangxi Medical University, Guangzhou First People's Hospital, Peking University People's Hospital, Peking University Shenzhen Hospital, Second Affiliated Hospital, Sun Yat-Sen University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shenzhen Hospital of Southern Medical University, Shenzhen Second People's Hospital, The First Affiliated Hospital of Zhengzhou University, The Third Xiangya Hospital of Central South University, Third Affiliated Hospital, Sun Yat-Sen University, Wuhan General Hospital of Guangzhou Military Command, Xiangya Hospital of Central South University, Zhongshan People's Hospital, Guangdong, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | relapse rate | 2 year | ||
Secondary | overall survival (OS) | 2 year | ||
Secondary | disease-free survival (DFS) | 2 year |
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