NCT00100737终止2 期
A Phase 2 Randomized, Open-Label, Controlled Trial of the Addition of 8 Weeks SC Administration of Aldesleukin (Rh-Interleukin-2 [IL-2]) to 4 Weeks of IV Administration of Rituximab in the Treatment of Rituximab Naïve Subjects With Follicular Non-Hodgkin's Lymphoma, Refractory or Relapsed After Previous Chemotherapy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 300
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to determine whether interleukin-2 given 3 times weekly for 8 weeks in combination with rituximab is effective and safe when compared to rituximab given alone in the treatment of follicular NHL subjects that have never received rituximab as a treatment and are refractory or relapsed after previous chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •CD20+ follicular B-cell non-hodgkin's lymphoma with at least 1 site of measurable disease.
- •Previous treatment with 1 to 4 prior chemotherapy regimens
- •ECOG performance status of greater than or equal to 2
- •Life expectancy of greater than 18 weeks
- •Meet safety lab requirements and organ function tests
排除标准
- •Prior treatment with rituximab or IL-2
- •Prior radioimmunotherapy including Zevalin or Bexxar
- •5 or more prior chemotherapy regimens
- •Clinically significant cardiac disease, lung dysfunction, autoimmune disease, thyroid disease, active infection, unstable psychiatric condition, or HIV infection.
- •History of allogenic bone marrow transplant
- •Female subjects that are pregnant or breast feeding
- •Immunosuppressive therapy including corticosteroids or investigational agents within 4 weeks prior to the planned start of study treatment
研究者
研究点 (2)
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