EUCTR2016-003409-33-SE进行中（未招募）1 期
Optimizing 6-mercaptopurine therapy in pediatric acute lymphoblastic leukemia by using allopurinol. Clinical study in children 1-19 years on maintenance therapy for acute lymphoblastic leukemia.
Västra Götaland Regionen0 个研究点目标入组 75 人开始时间: 2016年10月12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
- 75
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
入选标准
- •Children with acute lymphoblastic leukemia who have completed intensive chemotherapy and have started on maintenance therapy fulfilling criteria below
- •Treatment according to NOPHO ALL2008 based protocols
- •Age 0-18y at time of initial diagnosis
- •TPMT wild type
- •Written informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 75
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Mature B cell lymphoblastic leukemia
- •t(9;22) positive acute lymphoblastic leukemia
- •Unknown TPMT status or presence of TPMT mutation (both heterozygous and homozygous)
- •Known intolerance to any of the chemotherapeutic drugs in the protocol.
- •Major organ failure precluding administration of planned chemotherapy.
- •Lactating female or female of childbearing potential not using adequate contraception.
研究者
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