NCT01386398撤回3 期
Progression Free Survival (PFS) Comparison Between Suberoylanilide Hydroxamic Acid (SAHA, Vorinostat TM) in Combination With Bortezomib (Velcade TM) and SAHA Alone in Refractory or Recurrent Advanced CTCL. A Randomized Study.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Vorinostat and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether vorinostat is more effective when given alone or when given together with bortezomib in treating patients with refractory or recurrent cutaneous T-cell lymphoma.
PURPOSE: This randomized phase III trial is studying how well vorinostat works when given alone compared with vorinostat given together with bortezomib in treating patients with refractory or recurrent stage IIB, stage III, or stage IV cutaneous T-cell lymphoma.
详细描述
OBJECTIVES:
Primary
- To determine if the combination of bortezomib plus vorinostat (SAHA) is more effective than vorinostat alone, in terms of prolonging progression-free survival, in patients with stage IIB-IV cutaneous T-cell lymphoma who have failed prior therapy.
Secondary
- To determine the overall survival of these patients.
- To determine the response rate in these patients.
- To determine the time to progression in these patients.
- To determine the duration of response in these patients.
- To determine the incidence of second cancers in these patients.
- To determine the acute and late toxicity of this regimen in these patients.
- To determine if translational research may provide insight into disease mechanism and identify biomarkers useful for prediction of treatment response. (Exploratory)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
结局指标
主要结局
Progression-free survival
次要结局
- Time to progression
- Duration of response
- Second cancers
- Acute and late toxicity
- Overall survival
- Response rate
研究者
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