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临床试验/NL-OMON47149
NL-OMON47149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 - DCOG Protocol ALL-11

Stichting Kinderoncologie Nederland0 个研究点目标入组 770 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
770

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
2 至 99(—)

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

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
Stichting Kinderoncologie Nederland

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