Nordic Society of Paediatric Haematology and Oncology Treatment Protocol for Children (1.0 - 17.9 Years of Age) and Young Adults (18-45 Years of Age) With ALL. Efficacy of Individualised 6MP Dosing During Consolidation Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 775
- 试验地点
- 6
- 主要终点
- Fraction of patients that become MRD-negative at treatment days 85 and/or 92 (end-of-consolidation) and event-free survival. MRD is measured either by Flow-cytometry (for PreB-ALL patients) or PCR for clonal generearrangements(for T-ALL patients)
研究概览
简要总结
The purpose of this study is to increase the fraction of patients, who become MRD-negative during consolidation for the non-HR ALL group through individualized intensification of the 6MP-dosage days 30-85.
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 increase the fraction of patients, who become MRD-negative during consolidation for the non-HR ALL group through individualised intensification of the 6MP-dosage days 30-85. We will additionally measure EFS and toxicity as secondary end points of effect.
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
- •Mixed lineage 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
- •TPMT-deficiency
研究组 & 干预措施
6MPfixed
Fixed dose 6-mercaptopurine days 30-85
干预措施: 6MPfixed (Drug)
6MPindividualized
Individualized dose increments of 6-mercaptopurine days 30-85
干预措施: 6MPindividualized (Drug)
结局指标
主要结局
Fraction of patients that become MRD-negative at treatment days 85 and/or 92 (end-of-consolidation) and event-free survival. MRD is measured either by Flow-cytometry (for PreB-ALL patients) or PCR for clonal generearrangements(for T-ALL patients)
时间窗: 6 years
次要结局
- Toxicity of treatment, degree of myelo-, hepato- and renal toxicity; and development of asparaginase antibodies.(6 years)
研究者
Kjeld Schmiegelow
Professor
Rigshospitalet, Denmark