NCT00222612Unknown4 期
Medical Research Council Working Party on Leukaemia in Children UK National Acute Lymphoblastic Leukaemia (ALL) Trial: UKALL 2003
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 2,100
- 试验地点
- 1
- 主要终点
- Event free survival
研究概览
简要总结
A randomised trial for children with acute lymphoblastic leukemia, using the detection of minimal residual disease to define risk groups, aiming to answer the questions:
- Can treatment be reduced without compromising efficacy in a MRD-defined low risk group?
- Does further post-remission intensification improve outcome for a MRD-defined high risk group?
- Measure the Quality of Life impact of the different treatment arms on the children and their families.
详细描述
Randomisations
Patients will be assigned to MRD risk groups based on day 29 and post consolidation MRD results and randomised as follows:
- MRD Low Risk Group (MRD negative at day 29 and week 11 or positive <1 x 10-4 at day 28 and negative at week 11) will continue on previously assigned Regimens (A or B) but randomised between two delayed intensifications and one delayed intensification.
- MRD High Risk Group (MRD positive > 1 x 10-4 at day 29) randomised between previously assigned Regimen (A or B) and Regimen C.
- MRD Indeterminate Group (No MRD result or MRD positive <1 x 10-4 at day 29 and at week 11) will continue on previously assigned Regimen (A or B) and received two delayed intensifications
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
A or B with 2DI
Active Comparator
3 or 4 drug induction plus 2 delayed intensifications
干预措施: Standard childhood UK ALL protocol (Drug)
C plus 2DI
Experimental
Intensified treatment including Capizzi maintenance
干预措施: Intensified treatment including Capizzi maintenance (Drug)
A or B with 1DI
Experimental
Reduced intensity treatment
干预措施: Reduced intensification (Other)
结局指标
主要结局
Event free survival
时间窗: 5 years
次要结局
- Survival(5 years)
- Quality of life(3 years)
研究者
研究点 (1)
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暂停
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