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临床试验/EUCTR2012-000067-25-NL
EUCTR2012-000067-25-NL进行中(未招募)1 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 - DCOG Protocol ALL-11

Princess Máxima Center for pediatric oncology0 个研究点目标入组 819 人开始时间: 2012年7月13日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
819

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1.Newly diagnosed patients with T-lineage or precursor-B lineage ALL (patients with mature B-ALL are not eligible)
  • 2.Age between = 1 and < 19 years
  • 3.Informed consent signed by parents/guardians and patient if 12 years or older
  • 4.Diagnosis ALL confirmed by DCOG laboratory
  • 5.Patient should be treated in a Dutch Childhood Oncology Centre
  • 6.Patient should be >3 months settled in The Netherlands at diagnosis
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 818
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 1
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1.Age = 19 years at diagnosis
  • 2.Age < 366 days at diagnosis (infant ALL); these patients are eligible for the Interfant protocol
  • 3.Patients with secondary ALL
  • 4.Patients with mature B-ALL (immunophenotypical or documented presence of karyotype t(8;14), t(2;8), t(8;22) and breakpoint as in B-ALL)
  • 5.Patients with relapsed ALL
  • 6.Pre-existing contra-indications for treatment according to (parts of) protocol ALL-11.
  • 7.Essential data missing (in consultation with the protocol chairman)
  • 8.Treatment with systemic corticosteroids and/or cytostatics in a 4-week interval prior to diagnosis. One exception is the use of corticosteroids as emergency treatment.
  • 9.Patients with Ph-positive ALL (documented presence of t(9;22)(q34;q11) and/or of the BCR/ABL fusion transcript). These patients will be transferred to the EsPhALL protocol in induction according to the guidelines of the EsPhALL protocol.

研究者

发起方
Princess Máxima Center for pediatric oncology

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