Fludarabine, BBR 2778 (Pixantrone) and Rituximab (FP-R) vs Fludarabine and Rituximab (F-R) for Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 8
- 主要终点
- progression-free survival
研究概览
简要总结
BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and reduced delayed cardiotoxicity in animal models compared to reference standards. This cytotoxic agent has structural similarities to mitoxantrone as well as general similarities to anthracyclines (such as the tricyclic central quinoid chromophore7).
This phase III study will compare the efficacy and safety of the combination BBR 2778, fludarabine, and rituximab with the combination fludarabine and rituximab in patients with relapsed or refractory indolent non-Hodgkin's lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
研究组 & 干预措施
Comparator
fludarabine and rituximab
干预措施: fludarabine and rituximab (Drug)
Experimental
fludarabine, rituximab, pixantrone
干预措施: fludarabine, rituximab, pixantrone (Drug)
结局指标
主要结局
progression-free survival
时间窗: day 64-71
次要结局
- response rate, survival, safety(every 21 days)