NCT00724360终止2 期
A Phase II Trial Evaluating the Safety and the Efficacy of Trastuzumab in Relapsed/Refractory HER2 Positive B-acute Lymphoblastic Leukemia Patients.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 16
- 主要终点
- Response rate: Response was defined either as complete response (CR), CR without recovery of platelet (CRp), or partial response (PR)
研究概览
简要总结
This is a multicenter open-label phase II trial of trastuzumab in patients with HER2 positive B-ALL in relapse, or with refractory disease. Herceptin is administered as a 4 mg/kg intravenous loading dose followed by 2 mg/kg weekly for at least 2 months and/or till progression. Response and HER2 expression are assessed each month by bone marrow aspirate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •age > 18 years
- •B-ALL in relapse
- •refractory B-ALL-performance status of 0-2 on the Eastern Cooperative Oncology Group scale
- •adequate hepatic and renal functions (AST or ALT <= 5 times the upper limit of normal creatinine < 2 times the upper limit of normal)
- •> 20% blasts in bone marrow,
- •> 30% of bone marrow blast population HER2 positive as assessed by immunophenotyping
排除标准
- •Previous treatment by trastuzumab
- •FEVG < 50%
结局指标
主要结局
Response rate: Response was defined either as complete response (CR), CR without recovery of platelet (CRp), or partial response (PR)
次要结局
- Trastuzumab efficiency concerning transfusional needs
- Overall survival
- Leukemia free survival
- cytogenetic response rate
- Trastuzumab tolerance profile
研究者
研究点 (16)
Loading locations...
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