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| Name | Class |
|---|---|
| Second Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Third Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Guangzhou First People's Hospital | OTHER |
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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.
Risk-stratified therapy based on cytogenetic and molecular characteristic 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 the important role of early treatment response presenting as minimal residual disease (MRD) in prognostic prediction. In this study, we perform risk stratification based on not only cytogenetic and molecular characteristic, but also MRD levels after three courses of chemo therapy. We stratified all patients into different risk groups according to the NCCN guild based on cytogenetic and molecular. Then we treat all patients with anthracycline combined with cytarabine regimens for two courses (First cycle: IDA 12mg/m2 or DNR 60mg/m2, d1-3, Ara-C 100mg/m2 d1-7; Second cycle: IDA 10mg/m2 or DNR 45mg/m2, d1-3, Ara-C 2g/m2 q12h, d1-3) . The patients without obtaining complete remission (CR) will go on one cycle of salvage therapy and then be bridged to allogeneic (allo-) hemopoietic stem cell transplantation (HSCT). Those acquiring CR will be given one course of high dose cytarabine (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.The patients with MRD negative in low risk group are given HDAC (Ara-C 2g/m2 q12h, d1-3) for 3 cycles. If MRD is continuously negative in this cohort, chemotherapy will be stopped and MRD will be continuously monitored to the third year after the diagnosis. The patients with MRD negative in medium risk group are suggested to receive allo-HSCT if a HLA-matched sibling donor is available, or autologous (auto-) HSCT after receiving HDAC regimen for one more cycle if no HLA-matched sibling donors are available. The patients with MRD positive in low or medium-risk group or the cases in high-risk group are going to be bridged into allo-HSCT if a donor is available including haploid donors. The aim of this study is to evaluate whether the new stratification system benefits AML patients with better OS and DFS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risk stratification | Risk stratification based on cytogenetic and molecular and MRD level after three courses of chemo therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Justified risk stratification based on MRD after three course chemo therapy | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| relapse rate | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | 2 year | |
| disease-free survival (DFS) | 2 year |
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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)
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All newly diagnosed AML exclusively of APL with age range from 14 to 60-year old.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qifa Liu | Contact | liuqifa628@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Qifa Liu | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology,Nanfang Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42410464 | Derived | Yu S, Liu H, Zhao W, Yu G, Shi P, Nie D, Sun Z, Liu Q, Shao R, Feng Z, Liang X, Zhang X, Du X, Xu X, Wang S, Zhang Q, Jiang Y, Zhang H, Guo Z, Dai M, Jiang X, Xu D, Huang F, Fan Z, Xu N, Liu Q, Liang Q, Liu C, Wu M, Wen G, Lin R, Jin H, Sun J, Wang Y, Xuan L, Zhang Y, Liu Q. Autologous transplant versus matched sibling donor transplant in intermediate-risk AML in CR1 with no detectable MRD: a biological assignment comparative study. Exp Hematol Oncol. 2026 Jul 6. doi: 10.1186/s40164-026-00807-y. Online ahead of print. | |
| 40437173 |
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| Wuhan General Hospital of Guangzhou Military Command |
| OTHER |
| Shenzhen Hospital of Southern Medical University | OTHER |
| Peking University Shenzhen Hospital | OTHER |
| Shenzhen Second People's Hospital | OTHER |
| Zhongshan People's Hospital, Guangdong, China | OTHER |
| First Affiliated Hospital of Guangxi Medical University | OTHER |
| Xiangya Hospital of Central South University | OTHER |
| The Third Xiangya Hospital of Central South University | OTHER |
| First Affiliated Hospital of Gannan Medical University | OTHER |
| Peking University People's Hospital | OTHER |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Chenzhou NO. 1 people's Hospital | UNKNOWN |
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|
| Derived |
| Zhang Y, Feng Z, Du J, Liu H, Yu S, Liang X, Zhao W, Zhang Q, Zhang X, Nie D, Sun Z, Du X, Xu X, Yu G, Shi P, Liu Q, Shao R, Qu H, Xiong W, Wang S, Jiang Y, Zhang H, Guo Z, Dai M, Jiang X, Xu D, Huang F, Fan Z, Xu N, Liu C, Wu M, Lin R, Jin H, Sun J, Liu Q, Xuan L. High-dose cytarabine with idarubicin consolidation for acute myeloid leukemia in first complete remission: a randomized controlled trial. Leukemia. 2025 Aug;39(8):1857-1864. doi: 10.1038/s41375-025-02655-x. Epub 2025 May 28. |
| ID | Term |
|---|---|
| D002869 | Chromosome Aberrations |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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