Phase II Trial Of Campath-1H In Patients With Relapsed/Refractory Advanced Mycosis Fungoides or Sezary Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 4
- 主要终点
- Determine response rate associated with Campath-1H therapy in patients with relapsed Mycosis Fungoides/Sezary Syndrome
研究概览
简要总结
RATIONALE: Monoclonal antibodies such as alemtuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with relapsed or refractory advanced mycosis fungoides or Sézary syndrome.
详细描述
OBJECTIVES:
- Determine the response rate of patients with relapsed or recurrent advanced mycosis fungoides or Sézary syndrome treated with alemtuzumab.
- Determine the toxicity of this drug in these patients.
OUTLINE: Patients receive alemtuzumab IV over 2 hours three times per week. Treatment continues for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 2 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
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment arm
alemtuzumab
干预措施: alemtuzumab (Biological)
结局指标
主要结局
Determine response rate associated with Campath-1H therapy in patients with relapsed Mycosis Fungoides/Sezary Syndrome
时间窗: At baseline, weekly while on treatment, then once when patient goes off study
Response rate associated with Campath-1H therapy in patients with relapsed Mycosis Fungoides/Sezary Syndrome will be assessed by medical photograph (skin lesion) measurements or by CT scan for internal lesions upon study entry, weekly while on study, then once when patient goes off study
Collect data on toxicity associated with Campath-1H therapy
时间窗: At baseline and then every 2 weeks while on therapy
Toxicity of this drug will be assessed upon study entry and then every 2 weeks while on therapy by blood tests
次要结局
未报告次要终点