A Phase II Study of Galiximab (Anti-CD80) for Patients With Relapsed/Refractory Hodgkin Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 110
- 主要终点
- Overall Response
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as galiximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.
PURPOSE: This phase II trial is studying how well galiximab works in treating patients with relapsed or refractory Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- To determine the response rate (complete and overall response) in patients with relapsed or refractory Hodgkin lymphoma (HL) treated with galiximab.
Secondary
- To assess the duration of response, progression-free survival, and overall survival of patients with relapsed or refractory HL.
- To assess the safety and tolerability of galiximab in patients with relapsed or refractory HL.
- To determine if FDG-PET correlates with outcome in patients with relapsed or refractory HL treated with galiximab.
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 120 Years（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
Overall Response
时间窗: Duration of treatment (up to 10 years)
Overall response is defined as achievement of a complete response (CR) or partial response (PR) as defined by the Revised Response Criteria for Malignant Lymphoma. CR: complete disappearance of all detectable disease PR: \>=50% decrease in the sum of the product of diameters of indicator lesions.
次要结局
- 12 Month Overall Survival Rate(12 months)
- 6 Month Progression Free Survival Rate(6 months)