Acute Myeloid Leukemia Clinical Trial
Official title:
The Efficiency of CAMS-2016 Trial for the Newly Diagnosed Pediatric Acute Myeloid Leukemia: A Prospective Single Centre Trial From China
The purpose of this study is to evaluate that whether the AML (acute myeloid leukemia)-CAMS (Chinese Academy of Medical Sciences)-2016 regimen, includes risk-stratified therapy and the use of Dasatinib in CBF (Core binding factor)-AML, can improve the outcome in childhood AML.
Primary AML includes CBF(Core binding factor)-AML and non-CBF-AML. After the second course of therapy, CBF-AML are stratified into two risk groups: low-risk children are defined as those with CR after MAE or CAG, high-risk children are those with CR after consolidation course 1 or IAE. Non-CBF-AML patients in remission are stratified into three risk groups: low-risk children are defined as those with t(1；11)(q21；q23) , GATA1, NPM1/IDH1/IDH2 without FLT3/ITD,or an age younger than 2 years without high-risk factors; high-risk children are those with CR after consolidation course 1 or IAE or with abnormalities of monosomy 7, 5q- , t(16;21), t(9;22) (Philadelphia chromosome [Ph1]), FLT3/ITD,-17/TP53, RPN1-MECOM, RUNX1-EVI1, MLF1-NPM1, PRDM16-RPN1, DEK-NUP214, ETV6(TEL)-HLXB9(MNX1), NUP98-NSD1; intermediate-risk children are those who were not in either a low-risk or high-risk group.Low-risk children were treated only with chemotherapy, regardless the availability of a suitable HSCT donor. All high-risk children were allocated to Allo-hematopoietic stem cell transplantation (HSCT) in the first remission, including unrelated bone marrow transplantation (BMT). Auto-HSCT is recommended for intermediate-risk children. No prophylactic cranial irradiation is included in the protocol. Patients are treated on an inpatient basis during each treatment phase. ;
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