The Individualized Treatment of 6-mercaptopurine in Children With Acute Lymphoblastic Leukemia in China
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- leukopenia
研究概览
简要总结
The purpose of this study was to assess the efficacy and safety of individualized treatment of 6-mercaptopurine (6-MP) in Chinese children with acute lymphoblastic leukemia, and to investigate the dose-concentration-response (DER) relationship between thiopurine metabolites and adverse events. The individualized administration of 6-MP was established in Chinese children with acute lymphoblastic leukemia.
详细描述
To inflict minimal pain on the child contributing blood samples, opportunistic sampling design was chosen to collect pharmacokinetic samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Confirmed diagnosis of acute lymphoblastic leukemia;
- •Age 1-18y at time of initial diagnosis;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Informed consent signed by the patients parents or guardians before initiation of the study.
排除标准
- •Ph-positive ALL, matrue B-cell ALL, BC-CML;
- •Secondary to immunodeficiency, second cancer；
- •Abnormal liver and kidney function;
- •Patients divided into intermediate or high risk groups according to the risk grouping criteria of the Chinese Children Cancer Group (CCCG) protocol-ALL 2015;
- •Patients who enrolled in another clinical trial;
- •Expected survival time less than the treatment cycle;
- •Patients with other factors that researcher considers unsuitable for inclusion
研究组 & 干预措施
Standard treatment regimen
6-mercaptopurine was administered according to the Chinese Children Cancer Group (CCCG) protocol-ALL 2015.
干预措施: 6-mercaptopurine (Drug)
Standard treatment regimen
6-mercaptopurine was administered according to the Chinese Children Cancer Group (CCCG) protocol-ALL 2015.
干预措施: Standard treatment (Procedure)
Individualized treatment regimen
6-mercaptopurine was administered on the basis of Chinese Children Cancer Group (CCCG) protocol-ALL 2015 combined with Clinical Pharmacogenetics Implementation Consortium (CPIC), genotypes and the concentrations of 6-TGN in red blood cells.
干预措施: 6-mercaptopurine (Drug)
Individualized treatment regimen
6-mercaptopurine was administered on the basis of Chinese Children Cancer Group (CCCG) protocol-ALL 2015 combined with Clinical Pharmacogenetics Implementation Consortium (CPIC), genotypes and the concentrations of 6-TGN in red blood cells.
干预措施: Individualized treatment (Procedure)
结局指标
主要结局
leukopenia
时间窗: 6 weeks
Leukopenia was graded by common toxicity criteria as follows: Grade 3, 1.0-2.0 × 109/L, and Grade 4, \< 1.0 × 109/L.
thiopurine-induced leukopenia
时间窗: 6-weeks
Resolution of leukopenia was determined after 6-MP dose reduction or discontinuation, both in the absence of other apparent causes for the leukopenia or its disappearance.
次要结局
- hepatotoxicity(6 weeks)
- 6-thioguanine nucleotides (6-TGN) concentrations in erythrocytes.(3 months)
- 6-methylmercaptopurine nucleotides (6-MMPN) concentrations in erythrocytes.(3 months)
研究者
Wei Zhao
Professor; Head of department of clinical pharmacy and pharmacology
Shandong University