NCT00235560已完成2 期
Rapamycin in Combination With Low-dose Aracytin in Elderly Acute Myeloid Leukemia Patients. A Study From the Groupe Ouest Est d'étude Des Leucémies Aiguës Myéloïdes (GOELAMS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- response rate
研究概览
简要总结
These study is designed to evaluate the tolerability and efficacy of sirolimus (rapamycin) in combination with low-dose aracytin in elderly AML.
详细描述
Evaluate the tolerability and efficacy of sirolimus (rapamycin) in combination with low-dose aracytin
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Informed consent
- •de novo or secondary LAM (CML excluded) not elligible for intensive chemotherapy.
- •Previously untreated
排除标准
- •Renal impairment (serum creatinin >2N)
- •Hepatic impairment (TGO ou TGP > 5N), une cholestase (Phosphatases Alcalines or gamma-GT > 5N),bilirubin > 3N
- •Blast crisis CML
- •Acute Promyelocytic Leukemia.
研究组 & 干预措施
Rapamycine
Experimental
干预措施: rapamycin (Drug)
结局指标
主要结局
response rate
次要结局
- tolerability
- bioclinical markers of response
研究者
研究点 (3)
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