NCT01453504已完成1 期
A Prospective, Randomized, Placebo-controlled, Multicenter, International Phase I/II Trial of RAD001 (Everolimus) in Combination With DHAP as Induction Therapy in Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Complete Remission Rate (CR)
研究概览
简要总结
The purpose of this trial is
- to determine the recommended dose of everolimus for a subsequent Phase II trial
- to determine the efficacy of everolimus plus DHAP
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •relapsed or refractory Hodgkin Lymphoma
- •age 18-60
- •histology confirmed relapse
排除标准
- •previous therapy with mTOR inhibitor
- •current CNS involvement
- •other primary malignant disease within the last 3 years
研究组 & 干预措施
Ever-DHAP
Active Comparator
Combination of Everolimus and DHAP
干预措施: DHAP (Drug)
Ever-DHAP
Active Comparator
Combination of Everolimus and DHAP
干预措施: Everolimus (Drug)
Placebo-DHAP
Placebo Comparator
干预措施: DHAP (Drug)
结局指标
主要结局
Complete Remission Rate (CR)
时间窗: 4 weeks
Phase II primary outcome measure
Dose Limiting Toxicity Rate (DLT)
时间窗: 4 weeks
Phase I primary outcome measure
次要结局
- Adverse event rate(4 weeks)
- Tumor status (assessed by CT) after chemotherapy(4 weeks)
- Tumor status (assessed by PET) after chemotherapy(4 weeks)
研究者
Prof. Dr. Peter Borchmann
Prof.
University of Cologne
研究点 (1)
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