NCT00099255已完成2 期
A Phase II Multi-Dose Study of SGN-30 (Anti-CD30 mAb) in Patients With Primary Cutaneous Anaplastic Large Cell Lymphoma, Large Cell Transformation of Mycosis Fungoides, and Lymphomatoid Papulosis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Seagen Inc.
- 入组人数
- 40
- 试验地点
- 26
- 主要终点
- To investigate the toxicity profile of SGN-30
研究概览
简要总结
This multi-center, phase II study will be conducted to define the toxicity profile and antitumor activity of SGN-30 in patients with pcALCL and other closely related lymphoproliferative disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
结局指标
主要结局
To investigate the toxicity profile of SGN-30
To determine the objective response rate in patients with pcALCL, T-MF, and LyP
To determine the duration of response in patients treated with SGN-30
次要结局
- To provide preliminary estimates of disease-free and overall survival rates in pcALCL and T-MF patients treated with SGN-30
- To determine the immunogenicity of SGN-30
研究者
研究点 (26)
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