Determinants of Mercaptopurine Toxicity in Paediatric Acute Lymphoblastic
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 500
- 主要终点
- Red blood cells (RBC) concentration of 6-mercaptopurine (6-MP)
研究概览
简要总结
The present study was conducted to assess the population pharmacokinetics of 6-mercaptopurine (6-MP) in Pediatric Acute Lymphoblastic Leukemia (ALL) and genetic polymorphisms
详细描述
The investigators' purpose was to identify genetic factors and metabolite concentrations associated with both hematological toxicity in patients with ALL maintained on 6-MP in Chinese.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have been diagnosed with Acute Lymphoblastic Leukemia
- •Childhood patients who were undergoing chemotherapy or continuous follow-up after completion of chemotherapy
- •Patients received the phase of maintenance therapy that included oral 6-MP (>4 weeks) and completion of ≥ 6 months according to the CCLG (Chinese Children's Leukemia Group) protocol-ALL 2015
排除标准
- •Patients with high-risk ALL (presence of higher-risk features: MRD ≥ 1% at 46 day, or age < 6 month and white blood cell (WBC) count ≥ 300×109/L with translocations t(9;22) (q34;q11) [BCR-ABL], t(4;11) (q21;q23) [AF4/MLL], t(1;19) (q23;p13) [E2A-PBX1] or other MLL-rearrangements) were removed
研究组 & 干预措施
Antitumor drugs
Mercaptopurine administered at standard dose for children with hematological neoplasms.
干预措施: Mercaptopurine (Drug)
结局指标
主要结局
Red blood cells (RBC) concentration of 6-mercaptopurine (6-MP)
时间窗: at second day after oral administration
To detect of RBC 6-MP metabolite concentrations and evaluate the association of metabolite concentrations and side effects
Genetic polymorphisms in Chinese patients with ALL
时间窗: at second day after oral administration
To detect the frequencies of genetic polymorphisms of Chinese patients receiving 6-MP for treatment of ALL
次要结局
未报告次要终点
研究者
Wei Zhao
Head of department of clinical pharmacy and pharmacology
Shandong University