EUCTR2009-012718-35-FR
进行中（未招募）
不适用
An open-label, randomised crossover pharmacokinetic, palatability and safety study to assess the bioavailability of a new 6MP oral liquid formulation by comparison to a currently registered 6MP 50 mg adult tablet (part A) followed by an open, non-randomised multiple-doses study with adjusted doses of 6MP oral liquid formulation (part B) in children with acute lymphoblastic leukaemia.
Only For Children Pharmaceuticals0 个研究点目标入组 48 人2010年2月22日
相关药物Puri-Nethol
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Only For Children Pharmaceuticals
- 入组人数
- 48
- 状态
- 进行中（未招募）
- 最后更新
- 14年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Inclusion criteria for both parts of the study:
- •Acute Lymphoblastic Leukaemia in complete remission
- •Patient under maintenance treatment for at least the last 3 months
- •Stable for at least 3 weeks with the same dosage of 6MP (i.e. not more than a 10% variation in dose over the three weeks)
- •Informed consent form signed by patients or guardians
- •Documented assent for children above 6 years
- •Inclusion criteria specific to part A:
- •Aged 12\-18 years old
- •Patients treated with a 6MP dose of at least 40 mg per day
- •TPMT genotyping for the two following polymorphisms (TPMT\* 3B 460 G\>A and TPMT\* 3C 719 A\>G) will be performed if not already available. Patient carrying at least one mutant allele for at least one of these two polymorphisms will be excluded
排除标准
- •Excluion criteria related to pathologies or treatments
- •Severe bone marrow suppression(White blood cell below\<1\.5 109/l, Absolute neutrophil count\<0\.5 109/l or Platelet count\<50 109/l)
- •Renal/hepatic impairment
- •Chronic or recurrent infectious disease especially respiratory or urinary tract
- •Performance level Karnofsky \= 50% for patients \> 10 years of age and Lansky \=50 for patients \= 10 years of age
- •Medical history of hypersensitivity to 6MP or drug excipients
- •Treatment by allopurinol
- •Treatment by aminosalicylates
- •Treatment with Probenecid, Trimethoprim, Penicillins, Phenylbutazone, NSAIDs, Phenytoin
- •Vaccination with live organism vaccines
结局指标
主要结局
未指定
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