NCT00083694已完成2 期
UARK, 98-032, Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- To evaluate the efficacy and safety of Thalidomide in patients with leukemia.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Thalidomide in patients with leukemia.
详细描述
Patients will take Thalidomide tablets at bedtime daily until remission. The dose will be increased gradually and modified according to side-effects. The drug will be given daily up to the time of complete remission then as long as it is beneficial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Diagnosis of refractory or relapsed leukemia: acute leukemia, CML, CLLm and MDS.
- •Signed informed consent, including patient agreeing to use safe contraceptive methods during the treatment and for at least 4 months after the treatment is completed
- •Serum creatinine < or = 2.5mg/dL
- •Serum bilirubin< or = 2.5mg/dL
- •Negative pregnancy test
- •Age 18 years or older
- •Performance status < or = 3
排除标准
- •Pregnant or lactating women
- •Concurrent treatment with cytotoxic chemotherapy, or radiation
- •History of seizures, neurotoxicity, or active CNS disease
- •Serious infections not controlled by antibiotics
结局指标
主要结局
To evaluate the efficacy and safety of Thalidomide in patients with leukemia.
次要结局
未报告次要终点
研究者
研究点 (2)
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