PEG-asparaginase During Two Treatment Courses in the Treatment of Childhood Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Determination of the dose that secures sufficient treatment during 14 days
研究概览
简要总结
The purpose of this study is
- to determine the correct dose for intramuscular administration
- to compare the frequency of antibody formation after intramuscular administration of native E.coli asparaginase and PEG-asparaginase during two treatment courses in the treatment of childhood lymphoblastic leukemia
详细描述
Asparaginase is used in the treatment of childhood lymphoblastic leukemia. Approximately 1/3 of the patients develops blocking antibodies against native E.coli asparaginase during the second exposure, so that they do not benefit from treatment and thus may have a worse prognosis.
PEG-asparaginase is less immunogenic so that fewer patients may develop antibodies during the second exposure.
There is no published study about the antibody formation after treatment of children with PEG-asparaginase during two treatment courses.
The first part of the study is a description of the pharmacokinetics of PEG-asparaginase after intramuscular administration in order to determine the correct dose.
The second part of the study is a comparison of antibody formation during two treatment courses after intramuscular administration og native E.coli asparaginase and PEG-asparaginase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1-17 years
- •Newly diagnosed ALL (high intensive)
- •Treated according to the NOPHO-2000 protocol
- •Treated at one of the Nordic pediatric oncology centers
排除标准
- •<1 year and >18 years
- •Newly diagnosed ALL other than high intensive
- •Not treated according to the NOPHO-2000 protocol
- •Not treated at one of the Nordic pediatric oncology centers
- •Allergy to the contents
- •Pancreatitis (Active or earlier)
结局指标
主要结局
Determination of the dose that secures sufficient treatment during 14 days
Determination of the frequency of antibody formation during treatment with PEG-asparaginase during two treatment courses
次要结局
- Comparison of 5-year EFS between groups