NCT00634452已完成1 期
A Phase 1, Open-label, Dose-escalation, Multidose Study of MDX-1401 Administered Weekly for 4 Weeks in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma
Bristol-Myers Squibb11 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2008年2月最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 11
- 主要终点
- Safety and Tolerability Profile
研究概览
简要总结
To establish the safety and tolerability profile of MDX-1401 in patients with relapsed or refractory Hodgkin's Lymphoma (HL).
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CD30-positive HL by immunohistochemistry or flow cytometry
- •Must have failed or relapsed following second line chemotherapy or radiation or failed/relapsed following autologous stem cell transplant
- •Bi-measurable disease
- •ECOG Performance Status of 0 - 2
- •Meet all screening laboratory values
排除标准
- •Previous treatment with any other anti-CD30 antibody
- •History of allogeneic transplant
- •Any tumor lesion greater than or equal to 10 cm in diameter
- •Any active or chronic significant infection
- •Underlying medical condition which will make the administration of MDX- 1401 hazardous
- •Concomitant corticosteroids, chemotherapy, investigational agents, other anti-HL biologics, or radiation therapy
结局指标
主要结局
Safety and Tolerability Profile
时间窗: Two years
次要结局
- Objective Response Rate (ORR)(Day 50)
- Tumor response assessment(Two year)
研究者
研究点 (11)
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