The Mutation Profile and Prognosis in Acute Myeloid Leukemia With IDH1/2 Mutation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1,015
- 试验地点
- 1
- 主要终点
- Incidence
研究概览
简要总结
Investigators have a prospective clinical cohort including 500 adult AML patients. And investigators have stored leukemia sample from these patients. In this program investigators will do mutation profile in these patients. Also, investigators will elucidate the incidence of IDH1/2 mutations in adult AML in China and elucidate the prognostic effect of IDH1/2 mutation in AML.
详细描述
In this program, first, investigators want to uncover mutation profiles in the 500 AML patients including AML1-ETO CBFb-MYH11, MLL translocation, NPM1, FLT3, DNMT3a, CEBPA, TET2, ASXL1, U2AF2, TP53, c-KIT, RUNX1, NRAS, KRAS, PTPN11 genetic alteration in addition to IDH1/2 mutation. These patients received regimen, which is consistent with NCCN and ELN guidelines. NPM1, FLT3, DNMT3a, CEBPA, TET2, ASXL1, U2AF2, TP53, c-KIT, RUNX1, NRAS, KRAS, PTPN11, and IDH1/2 genetic alteration will be detected by targeted next generation sequencing. AML1-ETO and CBFb-MYH11 will be detected by RT-PCR. MLL translocation will be detected by FISH(fluorescence in situ hybridization).Next, investigators will elucidate the incidence of IDH1/2 mutations in adult AML in China. Then investigators will investigate mutation profile in IDH1/2 mutation AML patients. Finally, investigators will elucidate the prognostic effect of IDH1/2 mutation in AML. At last, investigators will instigate how mutation profile affects the prognosis in IDH1/2 mutation AML patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of less than 60 years old;
- •Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL subtypes).
- •Adult patients are willing to participate in the study and sign the informed consent by themselves or by their immediate family. Patients under 18 years old willing to participate should have their legal guardians sign the informed consent.
排除标准
- •Patients with other blood diseases(for example, haemophiliacs) are excluded.
- •With mutation of breakpoint cluster region-Abelson(BCR-ABL) fusion gene and in need of tyrosine kinase inhibitors therapy;
- •Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;
- •Had other malignant tumor in need of treatment;
- •Patients with other factors which were considered unsuitable to participate in the study by the investigators.
结局指标
主要结局
Incidence
时间窗: Before treatment
Incidence is defined as the incidence of patients who carries IDH1/2 mutations
次要结局
- Relapse-Free Survival(RFS)(Up to 3 years)
- Overall Survival(OS)(Up to 3 years)