A Phase II Trial of the Treatment of Polycythemia Vera With Gleevec
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Stabilization of hematocrit
研究概览
简要总结
The purpose of this research study is to evaluate the safety and effectiveness of patients with Polycythemia Vera treated with Gleevec.
详细描述
Phlebotomy is a standard temporizing treatment for Polycythemia Vera. Performing repeated phlebotomies may lead to iron deficiency and can contribute to a rising platelet count. This may create additional problems, such as clots particularly in patients older than 50. There is reason to believe that the use of Gleevec may cause a decrease in the activity of the marrow so that patients may not require as many or any phlebotomies. Thus, spleen function may possibly improve by decreasing in size and patients' platelet counts may also improve.
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
- •Patients have diagnosis of Polycythemia Vera (PV). Patients may have newly diagnosed PV.
- •Patients may have previously interferon-alfa treated PV with documented resistance, refractoriness or intolerance to interferon-alfa.
- •Patients may have PV with inadequate control on hydroxyurea.
- •Performance status of 0, 1, or 2
- •Adequate end organ function, defined as the following:
- •total bilirubin <1.5 x upper limit of the normal range (ULN)
- •SGOT (AST) and SGPT (ALT) < 2.5 x ULN
- •creatinine < 1.5 x ULN
- •ANC > 1.5 x 109/L
- •Written voluntary informed consent.
排除标准
- •Female patients who are pregnant or breast-feeding.
- •Patients receiving busulfan within 6 weeks of Study Day
- •Patients receiving interferon-alpha within 4 weeks of Study Day
- •Patients receiving hydroxyurea within 2 weeks of Study Day
- •Patients with Grade III or IV cardiac problems as defined by the New York Heart Association Criteria.
- •Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable.
- •Patients previously treated with Gleevec.
- •Serum erythropoietin level > or = 25 units/microliter
- •Abnormal O2 saturation (by pulse oximetry) or arterial pO2 (by arterial blood gas).
研究组 & 干预措施
Study drug
Gleevec treatment
干预措施: Gleevec (Drug)
结局指标
主要结局
Stabilization of hematocrit
时间窗: Weekly for the first six week of treatment, then monthly for one year from study entry.
Platelet count maintenance a therapeutic range.
时间窗: Weekly for the first six weeks of treatment, then monthly for one year from study entry.
次要结局
- Splenomegaly (if existent)(Weekly for the first six weeks of treatment, then montly for one year from study entry.)
- Quality of life, performance status, side effects and complications during treatment.(Weekly for the first six weeks of treatment, then montly for one year from study entry.)