NCT00220285已完成2 期
A Phase II Open-label Study of SH L 749 in Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphomas
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 45
- 主要终点
- The incidence of critical toxicity
研究概览
简要总结
The purpose of this study is to investigate the antitumor effect and safety of the product for relapsed or refractory indolent B-cell non-Hodgkin's lymphomas.
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
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Platelet counts of >/= 100,000/mm3
- •Absolute neutrophil counts of >/= 1,200/mm3
- •Bone marrow involvement < 25%
排除标准
- •Patients who received hematopoietic stem cell transplantation, including bone marrow transplantation, peripheral blood stem cell transplantation, etc.
- •Patients presenting with marked bone marrow hypocellularity (any suspected bone marrow hypocellularity should be confirmed by bone marrow biopsy)
- •Patients with previous myocardial infarction within the past 1 year, with heart disease that requires treatment or with pulmonary dysfunction
- •Patients with serious concomitant diseases (cardiac failure, renal failure, etc.)
研究组 & 干预措施
Arm 1
Experimental
干预措施: Zevalin (SH L 749 , BAY86-5128) (Drug)
Arm 2
Experimental
干预措施: Zevalin (SH L 749 , BAY86-5128) (Drug)
结局指标
主要结局
The incidence of critical toxicity
时间窗: During treatment period
Best overall response rates (the percentage of patients who achieved PR or better response)
时间窗: After 9 weeks or 13 weeks
次要结局
- Safety evaluation(During treatment period)
- Complete response (CR or CRu) rates(After 9 weeks or 13 weeks)
- Progression-free survival (PFS)(After end of study)
研究者
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