An Open-Label, Randomized, Phase III Comparative Trial of BBR 2778 + Rituximab Versus Rituximab in the Treatment of Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma (NHL)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 800
- 试验地点
- 38
- 主要终点
- Compare the time to tumor progression (TTP) of the combination of BBR 2778 (pixantrone) + rituximab with that of rituximab alone
研究概览
简要总结
The purpose of this study is to determine whether combining pixantrone (BBR 2778, INN name pending) with the monoclonal antibody rituximab, leads to an increase in the period of patients' remission, compared to rituximab alone.
详细描述
This trial is being conducted in patients with indolent (or low-grade) non-Hodgkin's lymphoma, who have either relapsed or been refractory to previous treatment.
Pixantrone belongs to the DNA intercalator family of chemotherapy agents, which includes anthracyclines. DNA intercalators are commonly used to treat patients with indolent NHL, often in combination with the monoclonal antibody rituximab. This study represents the first large-scale, comparative trial in indolent NHL, designed to determine whether the response rate and time to tumour progression in patients treated with a combination of rituximab and a DNA intercalator, is significantly higher than seen in patients treated with rituximab alone.
This trial is randomized and controlled, which means that participating patients will be randomly assigned to one of two treatment groups:
- Patients treated with both pixantrone and rituximab, in combination
- Patients treated with only rituximab
This trial is expected to recruit around 800 patients in the US, Europe and Israel, with 400 patients recruited to each group.
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
- 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
- •Patients with relapsed or refractory indolent non-Hodgkin's lymphoma (NHL), including follicular lymphoma grade I and II
- •Presenting with an episode of progressive disease, following 1-5 prior treatments (with either radiation, chemotherapy or rituximab).
排除标准
- •Patients that failed to respond to previous rituximab treatment, or relapsed within 6 months of the first rituximab infusion
- •Patients known to have an allergic reaction to rituximab or murine derived proteins.
结局指标
主要结局
Compare the time to tumor progression (TTP) of the combination of BBR 2778 (pixantrone) + rituximab with that of rituximab alone
时间窗: For 5 years post treatment
次要结局
- To compare BBR 2778 + rituximab versus rituximab for:(For 5 years post treatment)