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.
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