A Phase II Study of VELCADE With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Response rate (complete response [CR], CR-unconfirmed [CRu], and partial response [PR])
研究概览
简要总结
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Giving bortezomib together with rituximab may kill more cancer cells.
PURPOSE: This randomized phase II trial is studying how well giving bortezomib together with rituximab works in treating patients with relapsed or refractory non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the response rate (complete response [CR], CR-unconfirmed [CRu], and partial response [PR]) in patients with relapsed or refractory indolent B-cell non-Hodgkin's lymphoma treated with bortezomib and rituximab.
Secondary
- Determine the response rate (CR, CRu, and PR) at the first disease response evaluation in patients treated with this regimen.
- Determine the overall CR rate (CR and CRu) in patients treated with this regimen.
- Determine the time to progression in patients treated with this regimen.
- Determine the duration of response in patients treated with this regimen.
- Determine the time to best response in patients treated with this regimen.
- Determine the safety and tolerability of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
bortezomib + rituximab
Arm I: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Patients also receive rituximab IV on days 1, 8, and 15 of course 1 only and on day 1 of course 2 only. Treatment with repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive bortezomib IV over 3-5 seconds on days 1, 8, 15 and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 only. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients in either arm may crossover to the other arm if treatment is found to be ineffective.
干预措施: bortezomib + rituximab (Drug)
结局指标
主要结局
Response rate (complete response [CR], CR-unconfirmed [CRu], and partial response [PR])
时间窗: 12 weeks
次要结局
- Response rate (CR, CRu, and PR) at the first disease response evaluation(12 weeks)
- Overall CR rate (CR and CRu)(12 weeks)
- Safety and tolerability(12 weeks)