Phase II Study of Cyclosporine in T-Cell Large Granular Lymphocytic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Frequency of cytopemic response
研究概览
简要总结
RATIONALE: Cyclosporine may improve low blood counts caused by hematologic cancer.
PURPOSE: Phase II trial to study the effectiveness of cyclosporine in treating patients who have low blood counts caused by hematologic cancer.
详细描述
OBJECTIVES:
- Determine the frequency of cytopenic response in patients with T-cell large granular lymphocytic leukemia treated with cyclosporine.
OUTLINE: This is a multicenter study.
Patients receive oral cyclosporine every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 4 months for 1 year and then every 6 months for 9 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
cyclosporine
Patients receive oral cyclosporine every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 4 months for 1 year and then every 6 months for 9 years.
干预措施: cyclosporine (Drug)
结局指标
主要结局
Frequency of cytopemic response
时间窗: Up to 10 years
次要结局
未报告次要终点