ISRCTN75734403已完成不适用
Comparative pharmacokinetics, pharmacodynamics, efficacy and safety of two asparaginase preparations in children with previously untreated acute lymphoblastic leukaemia (ALL)
Medac GmbH (Germany)0 个研究点目标入组 32 人开始时间: 2006年1月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Previously untreated ALL
- •2. Morphological proof of ALL; bone marrow greater than 25% blasts
- •3. Aged 1 - 18 years
- •4. Informed consent
排除标准
- •1. Known allergy to ASNase
- •2. General health status according to Karnofsky/Lansky less than 40%
- •3. Pre-existing coagulopathy (e.g. haemophilia)
- •4. Pre-existing pancreatitis
- •5. Kidney insufficiency (creatinine greater than 220 umol/l)
- •6. Liver insufficiency (bilirubin greater than 50 umol/l; aspartate aminotransferase [ASAT] and alanine aminotransferase [ALAT] greater than 5 x upper limit of normal
- •7. Other current malignancies
- •8. Pregnancy, breast feeding
- •9. Patients suffering from mental disorders
研究者
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