NCT00094848已完成2 期
A Multi-Center, Open-Label, Dose-Escalation Study to Evaluate the Safety, Efficacy, and Exposure to TRM-1 (Fully Human Monoclonal Antibody to the TRAIL-R1) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 7
研究概览
简要总结
The purpose of this study is to evaluate the safety, efficacy and exposure to TRM-1 in subjects with relapsed or refractory Non-Hodgkin's Lymphoma (NHL).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary Inclusion Criteria:
- •Relapsed or refractory histologically confirmed Non-Hodgkin's Lymphoma
- •Previously treated with at least 1 therapeutic regimen and relapsed or progressed or failed to achieve a response after the last regimen
- •18 years of age or older
排除标准
- •Received a non-FDA approved investigational agent within the last 4 weeks
- •Received cancer therapies (chemotherapy, biological therapy [including hormonotherapy], radiation therapy or immunosuppressants within the last 3 weeks, 8 weeks for monoclonal antibodies, radioimmunotherapy or nitrosourea
- •Eligible for a hematopoietic stem cell transplant (HSCT) or have had an autologous HSCT within the last 16 weeks
- •Prior history of an allogeneic HSCT
- •HIV, AIDS-related lymphoma, central nervous system (CNS) lymphoma, Hepatitis-B or Hepatitis-C
- •Infection requiring antibiotics within the last 4 weeks
- •Major surgery within the last 4 weeks
- •Pregnant or breast-feeding women
- •History of other cancers within the past 5 years
研究者
研究点 (7)
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