NCT00744081已完成2 期
Open-label Multicenter Trial of Glivec® (Imatinib Mesylate, Formerly Known as STI571) in Combination With Chemotherapy (MTC) in Patients With Refractory or Relapsed Acute Myeloid Leukemia (AML)
Goethe University1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2004年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- To show superiority in complete responses of combination therapy MTC plus Glivec in patients with refractory or relapsed AML compared to a historical control which was treated with MTC alone.
研究概览
简要总结
The purpose of this study is to show superiority in complete responses of combination therapy MTC plus Glivec in patients with refractory or relapsed AML compared to a historical control which was treated with MTC alone.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Refractory AML after primary therapy
- •First relapse after a safe previous diagnosis of de novo or secondary AML
- •Age > 18 years
- •Serum bilirubin < 2.0 mg/dl
- •Serum creatinine < 1.5 times the normal value or a creatinine clearance > 60 ml/min
- •ECG and heart echography prior to start of therapy without severe findings
- •Overall condition < 2 according to ECOG criteria
- •Life expectancy > 6 weeks
- •Written informed consent by patients with full legal capacity
排除标准
- •Serious secondary disease (clinically relevant cardiac disease, chronic- obstructive pulmonary disease, hepatic dysfunction, renal insufficiency)
- •Active secondary neoplasia (exception: adequately treated basalioma or epidermoid cancer and cervical carcinoma)
- •Known hypersensitivity to topoisomerase-I inhibitors
- •Overall condition > 2 according to ECOG criteria
- •Pregnant/breast feeding women
- •Serious intercurrent infections
结局指标
主要结局
To show superiority in complete responses of combination therapy MTC plus Glivec in patients with refractory or relapsed AML compared to a historical control which was treated with MTC alone.
次要结局
未报告次要终点
研究者
Lothar Bergmann
Principal Investigator
Goethe University
研究点 (1)
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