NCT00185393已完成3 期
Efficacy and Safety of Subsequent Treatment With [90]Y-Ibritumomab Tiuxetan Versus no Further Treatment in Patients With Stage III or IV Follicular Non-Hodgkin's Lymphoma Having Achieved Partial or Complete Remission After First Line Chemotherapy. A Prospective, Multicenter, Randomized Phase III Clinical Trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 414
- 试验地点
- 95
- 主要终点
- Progression free survival
研究概览
简要总结
The aim of the study is to test [90]Y-ibritumomab tiuxetan, a radioactive antibody, in patients with stage III or IV follicular lymphoma whose disease is in partial or complete remission after first line chemotherapy. The radioactive antibody will be compared with no further treatment to see which is better in the long term after standard lymphoma treatment.
详细描述
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
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
- 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
- •Non Hodgkin Lymphoma stage III or IV at timepoint of diagnosis
- •Patients who have achieved a remission after first line chemotherapy
- •No less than 6 weeks and no more than 12 weeks since last dose of chemotherapy
- •older than 18 years
- •written informed consent
排除标准
- •Any other anticancer treatment for NHL except the preceding first line chemotherapy
- •Prior radiation therapy
- •Patients who have not recovered from the toxic effects of the first line chemotherapy
- •Any other cancer or history of cancer less than 10 years ago
- •Patients with known HIV positivity
- •patients with pleural effusion or ascites
- •female patients who are pregnant or breast feeding (women of childbearing potential must have a negative serum pregnancy test at study entry)
- •Adults not employing an effective method of birth control during study treatment and 12 months thereafter
- •Patients unable or unwilling to comply with protocol
结局指标
主要结局
Progression free survival
时间窗: End of study
次要结局
- Overall survival(End of study)
- Quality of Life(End of study)
- ECG(End of study)
- Co-medication(Continous)
- Clinical and molecular response rates(End of study)
- Adverse events / Toxicity Grading(Continous)
- Clinical laboratory results(3 monthly)
- Vital signs / physical examination(3 monthly)
研究者
研究点 (95)
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