Glivec (Imatinib Mesylate) in the Treatment of Polycythemia Vera
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
- 主要终点
- Reduction of Haematocrit to less than 45%.
研究概览
简要总结
The purpose of this study is to determine the activity of Glivec 400 mg po daily, as single agent, in inducing a haematological response in Polycythemia Vera.
The patients will be asked to have additional bone marrow and blood samples collected: these samples will be used to evaluate how the disease is responding to the drug.
详细描述
Hematocrit <45% in men or <42% in women at 1°evaluation within 6 months In case of complete or partial responsiveness, experimental treatment will be continued until 12 months In case of disease progression or treatment failure, experimental drug will be withdrawn and patient will be out of the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Diagnosis of Polycythemia Vera requiring treatment with either phlebotomy or Hydroxyurea
- •Age >18 years
- •Signed written informed consent form
排除标准
- •Pregnancy or breast-feeding
- •Creatinine >3 max NV
- •Bilirubin >3 max NV
- •AST/ALT >3 max NV
- •Concomitant and severe psychiatric disorder
- •Concomitant neoplastic disease
研究组 & 干预措施
Imatinib Mesylate
400 mg/day by mouth for 6 months (+ 6 months in case of responsiveness)
干预措施: Imatinib Mesylate (Drug)
结局指标
主要结局
Reduction of Haematocrit to less than 45%.
时间窗: 6-12 months
次要结局
- Reduction of incidence phlebotomies.(6-12 months)
- Symptoms improvement in patients.(6-12 months)
- Response duration(6-12 months)
- Safety profile(6-12 months)
- Reduction in platelet count and spleen size(6-12 months)