EUCTR2016-003409-33-FI进行中（未招募）1 期
Optimizing 6-mercaptopurine therapy in paediatric acute lymphoblastic leukemia by using allopurinol - Allopurinol in maintenance
Queen Silvias Childrens and Adolescents Hospital0 个研究点目标入组 60 人开始时间: 2018年5月16日最近更新:
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
- 60
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
- •All children with standard or intermediate risk acute lymphoblastic leukemia, aged 0-18 years at time of diagnosis of leukemia and treated according to ALL2008 protocols and with TPMT wild type who start maintenance 2 phase are eligible.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •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
- •-Sever liver toxicity defined as persistent (= two weeks) elevation of either S-bilirubin > 50 ??mol/l or S-GPT > 20 x UNL (upper normal limit) or P-Protrombin complex > 1.5
- •-Reduced kidney function defined as S creatine = 2 x UNL
- •-Lactating female or female of childbearing potential not using adequate contraception
研究者
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