ChEmo-Genomics Based Treatment of Acute Myeloid Leukemia- CeGAL-IPC 2014-012
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- The proportion of patients for whom a treatment tailored according to chemogenomic data could be proposed to the investigator within a 21 days time-frame in at least 30% of cases.
研究概览
简要总结
Adult acute myeloid leukemia (AML) is a heterogeneous hematologic malignancy associated with poor prognosis, especially after relapse. High-throughput genomic studies have highlighted the importance of molecular alteration in the pathophysiology, clinical evolution and treatment response of AML. In addition, identification of specific gene mutation can be targeted by specific inhibitors, opening the way to personalized treatments. However, only a limited number of gene mutations are druggable or actionable, highlighting the need for additional information to guide treatment choices. Among them, new Drug Screening Tests (DST) allow for the screening of library of hundreds of drugs to ex-vivo patient-derived AML cells. Combination of genomic and pharmacologic approaches might therefore improve prediction of drug effects. There is an urgent need to bring these approaches into the clinic but feasibility trials are necessary before incorporating them into treatments strategies.The proposed study is a prospective multicentre feasibility study of a combined "chemo-genomic" approach in patients with advanced AML.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Diagnosis of acute myeloid leukemia according to WHO classification
- •Refractory or relapsed disease
- •ECOG performance status of <3
- •Life expectancy >3 months
- •Written informed consent
- •Affiliation to the French Social Security System.
排除标准
- •Diagnosis of Acute Promyelocytic Leukemia.
- •Patients deprived of liberty or placed under the authority of a tutor.
结局指标
主要结局
The proportion of patients for whom a treatment tailored according to chemogenomic data could be proposed to the investigator within a 21 days time-frame in at least 30% of cases.
时间窗: 24 months
次要结局
- Correlations between genomic alterations (identified by mutatome and transcriptome analyses) and drug sensitivity profiles(24 months)
