A Phase I Trial of BBR 2778 in Combination With Fludarabine, Dexamethasone and Rituximab in the Treatment of Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Determine MTD
研究概览
简要总结
The aim of this trial is to determine the appropriate dose of pixantrone to be used in this combination and obtain data on the combination's safety and activity profile.
详细描述
The FND-R regimen is commonly used in the treatment of indolent Non-Hodgkin's lymphoma (NHL) and contains the chemotherapy agents mitoxantrone, fludarabine, dexamethasone (a steroid) and the monoclonal antibody rituximab. In this trial we are replacing mitoxantrone with pixantrone, an agent with a similar chemical structure (both agents are DNA intercalators). The trial is being run in patients with relapsed or refractory indolent NHL and aims to define the appropriate dose of pixantrone to be used in this combination, as well as to obtain data on pixantrone's safety and activity profile in combination with these drugs.
This trial is expected to recruit up to 30 patients in the USA. Patients will be treated with the drug combination for up to eight months and then followed closely in the four-week period after the last administration. After that, patients will receive physician check-ups every three months.
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
- •Patients with relapsed or refractory indolent (low-grade) NHL
- •Who have received 1-3 prior treatments with chemotherapy
排除标准
- •Patients previously treated with fludarabine
- •Prior treatment with rituximab (Rituxan), unless there was a complete response (CR) or partial response (PR) to that treatment
- •Patients known to have an allergic reaction to rituximab, or to murine proteins.
结局指标
主要结局
Determine MTD
时间窗: Per cycle
次要结局
- Establish safety profile(per cycle)