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临床试验/NL-OMON29675
NL-OMON29675已完成3 期

Protocol ALL-11:Treatment study protocol of the Dutch Childhood Oncology Group for children and adolescents (1-19 year) with newly diagnosed acute lymphoblastic leukemia - SKION ALL-11

Prinses Máxima Centrum voor kinderoncologie0 个研究点目标入组 819 人开始时间: 待定最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
819

研究概览

简要总结

The DCOG ALL11 showed that the five-year survival for children with acute lymphatic leukaemia increased to 94%. The ALL11 included 800 Dutch children and examined modified treatment protocols for four subgroups. The modifications were found to have a positive effect on survival and quality of life. The effect of modified treatment in specific groups of children with leukaemia, including those with a so-called Ikaros abnormality (IFZF1del), was examined. In this study, these children received an extra year of chemotherapy in the 'maintenance phase' on top of the first two years of treatment. This modification led to a nearly three times lower risk of cancer recurrence: it only happened in 9% of them, compared to 26% of children in the previous treatment protocol. In the ALL-11 protocol, doctors and researchers also looked at the effect of less intensive treatment for three other groups of children. These included children with a DNA abnormality in their leukaemia cells that is associated with a very high cure rate (ETV6::RUNX1), and children with Down's syndrome who suffer a lot of side effects from therapy. These children were given a lower amount of anthracyclines, a particular type of chemotherapy that increases the risk of heart damage and infections. The modification proved to be a good choice: the children had the same or even better survival rate while their quality of life improved due to a lower risk of infections and less risk of heart damage."

研究设计

研究类型
Interventional

入排标准

年龄范围
0 至 17(—)

入选标准

  • •1. Nieuw gediagnostiseerde patienten met T- of precursor B ALL (patienten met Mature B-ALL zijn niet eligible) |

排除标准

  • •1. Leeftijd = 19 jaar bij diagnose |

研究者

发起方
Prinses Máxima Centrum voor kinderoncologie

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