NCT01419691已完成2 期
A Phase I Phase II Two-Step Study of the Oral Gold Compound Auranofin in Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL)/ Prolymphocytic Lymphoma (PLL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Response Rate
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of auranofin to treat patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or prolymphocytic lymphoma (PLL).
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
- •histologically confirmed B-cell chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), prolymphocytic leukemia arising from CLL/SLL or Richter's transformation according to WHO criteria who require therapy based on the 2008 revised IWCLL criteria.
- •Relapsed or refractory disease after receiving at least 1 prior therapy for CLL
- •At least 18 years old; ECOG status of 1 or less; life expectancy 2 months or greater
- •Adequate organ and marrow function (total bilirubin less than 1.5x IULN; ALT less than 2x IULN; serum creatinine less than 1.5x ULN)
排除标准
- •have had chemotherapy, radiotherapy or immunotherapy within 4 weeks prior to entering study
- •have not recovered from AEs due to agents administered more than 4 weeks prior
- •receiving any other investigational agent
- •known second malignancy that limits survival to less than 2 years
- •known HIV positive
- •uncontrolled intercurrent illness
- •pregnant or breastfeeding
研究组 & 干预措施
Phase 2 Dose
Experimental
Auranofin 6 mg orally in the morning / 6 mg orally in the evening
干预措施: auranofin (Drug)
结局指标
主要结局
Response Rate
时间窗: 24 months
type, incidence, severity, seriousness and relationship to auranofin of adverse events and any laboratory abnormalities
时间窗: 24 months
次要结局
未报告次要终点
研究者
研究点 (1)
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