PEG-asparaginase Treatment in the NOPHO ALL-2008 Protocol: Antibody Formation, Pharmacokinetics, Pharmacodynamics and Side Effects.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Asparagine depletion
研究概览
简要总结
Asparaginase is an important drug i the treatment of childhood leukaemia.
The aim of this project is to study the pharmacokinetics, pharmacodynamics and antibody development and hypersensitivity reactions during prolonged PEG-asparaginase treatment.
Study part 1) Asparaginase pharmacokinetics and pharmacodynamics during prolonged PEG-asparaginase treatment: A NOPHO ALL-2008 study
Study part 2) Asparagine depletion in cerebrospinal fluid: A NOPHO ALL-2008 study
Study part 3) A characterization of PEG-asparaginase hypersensitivity in children treated according to the NOPHO ALL 2008 protocol
Perspectives: New knowledge about PEG-asparaginase treatment regarding dosing, dosing interval, adverse effects and EFS, which may lead to improved future therapy
Patients: Children diagnosed with acute lymphoblastic leukaemia in the Nordic Countries
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 1 and 18 years old, diagnosed ALL and treated according to the NOPHO-ALL 2008 protocol and who have accepted to participate in this study
排除标准
- •Children that does not attend the NOPHO-ALL 2008 protocol but receives standard treatment
结局指标
主要结局
Asparagine depletion
时间窗: Up to 30 weeks of treatment
Blood samples and cerebrospinal fluid samples are collected at certain timepoints during 30 weeks of treatment with PEG-asparaginase. They are analyzed for asparagine, asparaginase-enzyme activity and asparaginase-antibodies.These measures tell about the effect of the drug, PEG-asparaginase.
次要结局
未报告次要终点
研究者
Louise Tram Henriksen
MD
Aarhus University Hospital