The Association Between Asparaginase Enzyme Activity Levels and Toxicities in Childhood Acute Lymphoblastic Leukaemia in NOPHOALL 2008
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,248
- 试验地点
- 1
- 主要终点
- Number of participants with asparaginase associated pancreatitis
研究概览
简要总结
Evaluation of the association between risk and severity of asparaginase associated toxicities and asparaginase enzyme activity levels in children with Acute Lymphoblastic Leukemia treated in the NOPHO-ALL 2008 protocol.
详细描述
Asparaginase treatment in acute lymphoblastic leukemia in children is jeopardized by a huge toxicity burden and the toxicities are often preventing further treatment. The most common asparaginase associated toxicities are hypersensitivity, pancreatitis, thromboembolism and osteonecrosis.
In the NOPHO ALL2008 protocol asparaginase associated toxicities have been registered since the protocol opened in July 2008. In addition asparaginase enzyme activity measurements have been done before every asparaginase administration and analyzed retrospectively.
This study evaluate the association between risk and severity of asparaginase associated toxicities and asparaginase enzyme activity levels in children with ALL treated in the NOPHO-ALL 2008 protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ALL, standard or intermediate risk
- •Included in the NOPHO ALL2008 protocol (July 2016 - February 2016)
- •Children (1-17,9 years at diagnosis)
排除标准
- •ALL: high risk disease, ph-, genetic predisposition, bilinear ALL
- •< 2 samples for asparaginase enzyme activity measurements
结局指标
主要结局
Number of participants with asparaginase associated pancreatitis
时间窗: July 2008 - February 2016
Number of participants with tromboembolism
时间窗: July 2008 - February 2016
Number of participants with hypersensitivity
时间窗: July 2008 - February 2016
Clinical allergy / silent inactivation.
Number of participants with osteonecrosis
时间窗: July 2008 - February 2016
次要结局
未报告次要终点
研究者
Birgitte Klug Albertsen
M.D., PhD, Associate Professor
Aarhus University Hospital