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临床试验/NCT00373906
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

Medical University of Vienna0 个研究点目标入组 16 人开始时间: 2006年9月8日最近更新:
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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
研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

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

申办方类型
Other

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