NCT00723346已完成1 期
Administration of Allogenic of Red Blood Cells Loaded L Asparaginase in Acute Lymphoblastic Leukemia Relapse.
ERYtech Pharma1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2006年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Duration of plasmatic asparagin depletion (< 2µmol/l)
研究概览
简要总结
Primary objective :
- To explore the relation between 3 doses of GRASPA and duration of asparagine depletion (< 2µmol/l)
Secondary objective :
- Pharmacokinetic / Pharmacodynamic parameters
- toxicity
- Study duration : 2 years
- Study treatment : Red blood cells loaded with L asparaginase versus native L asparaginase
- Associated treatments : COPRALL chemotherapy
- Randomization : centralised randomisation on scratching list
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
- 1 Year 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject between 1 and 55 year old
- •Subject with acute lymphoblastic leukaemia or lymphoblastic lymphoma (excluded burkitt lymphoma) who have relapsed after first remission (medullary or SNC relapse)
- •Or patient who still refractory to first line chemotherapy for an ALL
- •Patient who gave written informed consent (2 parents for children)
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
干预措施: GRASPA (Biological)
2
Experimental
干预措施: GRASPA (Biological)
3
Experimental
干预措施: GRASPA (Biological)
4
Active Comparator
干预措施: native L asparaginase (Drug)
结局指标
主要结局
Duration of plasmatic asparagin depletion (< 2µmol/l)
时间窗: PK points
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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