EUCTR2009-012718-35-DK进行中（未招募）不适用
An open-label, randomised crossover pharmacokinetic, palatability and safety study to assess the bioavailability of 5ml of a new 6MP oral liquid formulation by comparison to a currently registered 6MP 50 mg (Purinethol®) 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 人开始时间: 2010年4月22日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
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
- •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 parents or guardians
- •Documented assent for children above 6 years
- •Inclusion criteria specific to part A:
- •Aged 12-29 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
- •Inclusion criteria specific to part B:
- •Aged 2-17 years old
- •TPMT genotyping for the two polymorphisms (TPMT* 3B 460 G>A and TPMT* 3C 719 A>G) will be performed if not already available. Any TPMT deficiency genotype will be authorised to enter part B of the study. But patient carrying out at least one mutant allele for these two polymorphisms needs an adjustment of 6MP dose. The dose of 6MP oral liquid formulation will be adapted according to doctor’s prescription.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •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
- •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, (excepted for patients on stable doses of Trimethoprim for at least 2 months prior to the inclusion in the trial) Penicillins, Phenylbutazone, NSAIDs, Phenytoin
- •Vaccination with live organism vaccines
- •Exclusion criteria related to the population
- •Planned travel outside the study area for a substantial portion of the study period
- •Intake of any experimental treatment during the past three months preceding inclusion or during the study
- •Patient who, in the judgment of the investigator is not likely to be compliant during the study
- •Patient linguistically or psychologically unable to understand the information given or formulate his/her assent to be involved
- •Parents or guardians linguistically or psychologically unable to understand the information given or to give their informed consent or who refuse to give their consent in writing
- •Patient or parents or guardians who cannot be contacted by phone in case of emergency
- •Extra exclusion criterion for girls of childbearing potential
- •Pregnancy or breast-feeding
研究者
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