NCT00373906已完成2 期
Phase II Trial pf Bortezomib in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- to evaluate the clinical potential of bortezomib
研究概览
简要总结
Bortezomib for treatment of disseminated MALT lymphoma or at relapse following HP -eradication,or chemotherapy or radiation.
详细描述
The objectives of this study are to evaluate the effectivity and the safety of bortezomib in patients with disseminated MALT lymphoma or at relapse following HP-eradication, or chemotherapy or radiation.
It is a phase II prospective single arm study with a target sample of 16 patients. 1.5mg/m2 Bortezomib is given intravenously on day 1,4,8,11 every three week, for a maximum of 8cycles.
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 histologically confirmed MALT lymphoma with measurable disease (stage I-IV)
- •with first or greater relapse after HP-eradication, radiation or chemotherapy ,
- •age > 18 years
- •must be able to tolerate therapy and have adequate cardiac, renal and hepatic function
- •ECOG status of <_ 2
- •must be capable of understanding the purpose of the study and given written informed consent
排除标准
- 未提供
结局指标
主要结局
to evaluate the clinical potential of bortezomib
to induce objective/histologic responses in patients with MALT-Lymphoma
次要结局
- to evaluate the impact of bortezomib on progression free survival
研究者
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