NCT01966497Unknown不适用
Observational Study of Patients Older Than 60 Years and With Acute Myeloblastic Leukemia Who Are Administered Standard Chemotherapy Based on Idarubicine-cytarabine
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- cumulative incidence of failures
研究概览
简要总结
The main objective of this observational survey is to estimate the incidence, the typology, and the evolution of patients with acute myelobalstic leukemia, aged more than 60 years old. In this age group (aged more than 60y), three groups of patients with very different response rates and late outcome can be delineated with specific standard chemotherapy.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 60 years or more
- •With a morphologically proven diagnosis of AML according to WHO 2008 classification
- •Not previously treated for AML
- •Signed informed consent.
排除标准
- •APL in the WHO classification.
- •Ph1-positive AML or prior Ph1-positive disease
- •AML evolving from a prior MPN in the WHO 2008 classification.
- •Prior tumor, if not stable for at least two years, except in-situ carcinoma and skin carcinoma
- •ECOG Performance Status Score > 3
- •Positive serology for HIV or HTLV1, or active viralinfection for HBV and HBC.
- •Severe uncontrolled infection at inclusion time.
- •Psychiatric disease or an history of non-complianceto medical regimens or patients considered potentially unreliable.
- •Absence of Health Care Insurance
结局指标
主要结局
cumulative incidence of failures
时间窗: 9 months
failures include * resistant disease defined according to the IWG AML response criteria * hypoplastic marrow after D42 and absence of myeloidrecovery * early relapse up to 9 months from CR : Either AML relapse as in the IWG classification or MDS relapse
次要结局
- response rate(9 months)
- relapse rate(within 2 years after inclusion)
- overall survival(within 2 years after inclusion)
- adverse events(within 2 years after inclusion)
研究者
研究点 (1)
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