NCT00836043终止不适用
Safety, Effectiveness and Patient Acceptance of the Treatment With MabCampath in Chronic Lymphocytic Leukemia (CLL)
Genzyme, a Sanofi Company0 个研究点目标入组 6 人开始时间: 2008年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 主要终点
- Efficacy related variables are patient's condition, physician's assessment of efficacy and tolerability, information whether application could be completed, clinical and laboratory findings. Safety Variables.
研究概览
简要总结
This study will collect data on safety, effectiveness and patient acceptance of MabCampath treatment under daily life conditions.
详细描述
As of 29 May 2009, the clinical trial sponsor is Genzyme Corporation. NOTE: This study was originally posted by sponsor Schering AG, Germany, which was subsequently renamed to Bayer Schering Pharma AG, Germany.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •In- and outpatients suffering from CLL, who are treated with Mab Campath, and are routinely monitored with PCR (Polymerase Chain Reaction) for CMV infection during MabCampath treatment and for at least 2 months following completion of treatment.
排除标准
- •In accordance with Summaries of Product Characteristics (SPC).
研究组 & 干预措施
Group 1
干预措施: Alemtuzumab (MabCampath) (Drug)
结局指标
主要结局
Efficacy related variables are patient's condition, physician's assessment of efficacy and tolerability, information whether application could be completed, clinical and laboratory findings. Safety Variables.
时间窗: After first cycle of treatment, e.g. 12 weeks, then after 9 months
次要结局
未报告次要终点
研究者
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