NCT00157274Unknown2 期
Phase II Study of Alemtuzumab in Patients With Advanced Mycosis Fungoides/Sezary Syndrome
Latin American Cooperative Onco-Haematology Group - Peru2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2005年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Event free survival
研究概览
简要总结
The investigators designed a compassionate basis phase II study for refractory/relapsed mycosis fungoides/Sezary syndrome consisting of alemtuzumab (Campath) for primary evaluation of overall response and time to relapse. Other goals to consider are toxicity and time to new therapy.
详细描述
- 20 relapsed or refractory advanced mycosis fungoides/Sezary syndrome patients are scheduled with gradually escalated doses (3 mg, 10 mg , and 30 mg) on sequential days during the first week, followed by 30 mg three times a week until 12 weeks.
- Patients must have serology negative for human T-lymphotropic virus 1 (HTLV-1) and until three different regimens of chemotherapy.
- Follow up for one year after last cycle of alemtuzumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Above 18 years old
- •Eastern Cooperative Oncology Group (ECOG) 0-2
- •Liver and renal function test less than twice upper label
- •No active infection
- •Written informed consent
- •One to three regimens of previous chemotherapies
排除标准
- •Abnormal renal or hepatic function
- •Mycosis fungoides/Sezary syndrome in transformation
- •Pregnancy
- •Lactation
结局指标
主要结局
Event free survival
Overall response
Time to relapse
次要结局
- Toxicity
研究者
研究点 (2)
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