Dose Individualization of Antineoplastic Drugs and Anti-Infective Drug in Children with Hematoplastic Disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 2
- 主要终点
- change of plasma concentration of bortezomib
研究概览
简要总结
The investigators' purpose was to assess the feasibility of dosage individualization of the commonly used antineoplastic drugs and anti-infective drugs in children with hematoplastic disease.
详细描述
The investigators' purpose was to assess the feasibility of dosage individualization of the commonly used antineoplastic drugs and anti-infective drugs based on the opportunistic sampling strategy in children with confirmed or suspected hematological neoplasms.
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 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be diagnosed with hematological neoplasms
- •Antineoplastic drugs or anti-infective drugs used as part of regular treatment
排除标准
- •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
Antineoplastic Drugs and Anti-infective Drugs
Bortezomib;eltrombopag;imatinib;dasatinib, pegaspargase and anti-infective drugs administered at standard dose for children with hematological neoplasms.
干预措施: Bortezomib (Drug)
Antineoplastic Drugs and Anti-infective Drugs
Bortezomib;eltrombopag;imatinib;dasatinib, pegaspargase and anti-infective drugs administered at standard dose for children with hematological neoplasms.
干预措施: Eltrombopag (Drug)
Antineoplastic Drugs and Anti-infective Drugs
Bortezomib;eltrombopag;imatinib;dasatinib, pegaspargase and anti-infective drugs administered at standard dose for children with hematological neoplasms.
干预措施: Imatinib (Drug)
Antineoplastic Drugs and Anti-infective Drugs
Bortezomib;eltrombopag;imatinib;dasatinib, pegaspargase and anti-infective drugs administered at standard dose for children with hematological neoplasms.
干预措施: dasatinib (Drug)
Antineoplastic Drugs and Anti-infective Drugs
Bortezomib;eltrombopag;imatinib;dasatinib, pegaspargase and anti-infective drugs administered at standard dose for children with hematological neoplasms.
干预措施: Pegaspargase (Drug)
Antineoplastic Drugs and Anti-infective Drugs
Bortezomib;eltrombopag;imatinib;dasatinib, pegaspargase and anti-infective drugs administered at standard dose for children with hematological neoplasms.
干预措施: Anti-Infective Drugs (Drug)
Antineoplastic Drugs and Anti-infective Drugs
Bortezomib;eltrombopag;imatinib;dasatinib, pegaspargase and anti-infective drugs administered at standard dose for children with hematological neoplasms.
干预措施: PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor (Drug)
结局指标
主要结局
change of plasma concentration of bortezomib
时间窗: at(0-0.5)h,(0.5-3)h,(24-48)h,(48-72)h hours after administration
To detect the plasma concentrations of bortezomib after administration
change of plasma concentration of eltrombopag
时间窗: at (0.5-3)h,(3-6)h,(10-14)h,(20-24)h hours after oral administration
To detect the plasma concentrations of eltrombopag after administration
change of plasma concentration of imatinib
时间窗: at (0.5-2)h,(2-4)h,(10-14)h,(20-24)h hours after oral administration
To detect the plasma concentrations of imatinib after administration
plasma concentration of anti-infective drug
时间窗: through study completion, an average of 14 days
To detect the plasma concentrations of anti-infective drug after administration
change of plasma concentration of dasatinib
时间窗: at(0-0.5)h,(0.5-3)h,(10-14)h,(20-24)h hours after oral administration
To detect the plasma concentrations of dasatinib after administration
change of plasma concentration of pegaspargase
时间窗: at Day-1,Day(0-1),Day(3-5),Day(8-10),Day(13-14) after administration
To detect the plasma concentrations of pegaspargase after administration
次要结局
未报告次要终点
研究者
Wei Zhao
Professor; Head of department of clinical pharmacy and pharmacology
Shandong University