NOPHO Treatment Protocol for Children (1.0 - 17.9 Years of Age) and Young Adults(18.0-45.0 Years) With Acute Lymphoblastic Leukemia. Intermittent Versus Continuous PEG-asparaginase for Asparagine Depletion
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 650
- 试验地点
- 6
- 主要终点
- Event Free Survival
研究概览
简要总结
The purpose of this study is to investigate if intramuscular PEG-asparaginase administered either at six or two week intervals from day 92 until 8 months from diagnosis for patients with non-HR ALL will result in equal probability of Event Free Survival
详细描述
20% of children with ALL still fails to be cured. The ALL-2008 protocol is a treatment and research protocol that aims to improve the overall outcome of Nordic children and adolescents with ALL in comparison with the ALL-2000 protocol and previous NOPHO protocols.
The specific and primary objectives of the randomised study is:
To test if intramuscular PEG-asparaginase administered either at six or two week intervals from day 92 until 8 months from diagnosis for patients with non-HR ALL will result in equal probability of EFS. As secondary endpoints asparaginase antibody production and toxicity including allergic reactions in the treatment-arms will be analysed
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 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Childhood ALL
- •All mandatory biological data are available6
- •Written informed consent has been obtained
排除标准
- •Bilineage ALL
- •Pre-treatment with glucocorticosteroids or other antileukemic agents for more than 1 week
- •ALL predisposition syndromes
- •Previous cancer
- •Off protocol administration of additional chemotherapy during induction therapy
- •Sexually active females not using contraception
- •No allergic reactions to PEG Asparaginase
研究组 & 干预措施
PEG-asparaginase 6 weeks intervals
PEG-asparaginase (1.000 IU/m2/dose) given at six weeks intervals (from week 13 after diagnosis to week 33).
All additional therapy (High Dose Methotrexate, Vincristin, Dexamethasone, 6-Mercaptopurine, doxorubicin, intrathecal chemotherapy) is the same in both arms.
干预措施: PEG Asparaginase at six weeks interval (Drug)
PEG-Asparaginase 2 weeks intervals
PEG-asparaginase (1.000 IU/m2/dose) given at two weeks intervals (from week 13 after diagnosis to week 33).
All additional therapy (High Dose Methotrexate, Vincristin, Dexamethasone, 6-Mercaptopurine, doxorubicin, intrathecal chemotherapy) is the same in both arms.
干预措施: PEG Asparaginase at two weeks interval (Drug)
结局指标
主要结局
Event Free Survival
时间窗: 6 years
次要结局
- Secondary Outcome Measures are toxicity (special focus on thrombosis, pancreatitis, and allergic reactions), the formation of silent antibodies, and the influence of antibody production on the EFS.(6 years)
研究者
Kjeld Schmiegelow
Professor
Rigshospitalet, Denmark