A Phase I Study Evaluating Combined Zevalin (Ibritumomab Tiuxetan) and Valcade (Bortezomib) in Relapsed/Refractory Low-Grade or Follicular B-Cell and Mantle Cell Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose of bortezomib
研究概览
简要总结
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, and radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them without harming normal cells. Giving bortezomib together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with rituximab and yttrium Y 90 ibritumomab tiuxetan in treating patients with relapsed or refractory low-grade, follicular, or mantle cell non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) of bortezomib in combination with rituximab and yttrium Y 90 ibritumomab tiuxetan in patients with relapsed or refractory low-grade, follicular B-cell, or mantle cell non-Hodgkin's lymphoma.
- Determine the dose-limiting toxicity of this regimen in these patients.
Secondary
- Determine the response rate in patients treated with this regimen.
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 120 Years（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
Zevalin + Velcade Single Arm Study
Zevalin (Ibritumomab Tiuxetan) and Velcade (Bortezomib)
干预措施: rituximab (Biological)
Zevalin + Velcade Single Arm Study
Zevalin (Ibritumomab Tiuxetan) and Velcade (Bortezomib)
干预措施: bortezomib (Drug)
Zevalin + Velcade Single Arm Study
Zevalin (Ibritumomab Tiuxetan) and Velcade (Bortezomib)
干预措施: yttrium Y 90 ibritumomab tiuxetan (Radiation)
Zevalin + Velcade Single Arm Study
Zevalin (Ibritumomab Tiuxetan) and Velcade (Bortezomib)
干预措施: Indium 111 ibritumomab tiuxetan (Radiation)
结局指标
主要结局
Maximum tolerated dose of bortezomib
时间窗: 2 years
Dose-limiting toxicity
时间窗: 8 weeks
次要结局
- Response rate(5 years)