Efficacy and Safety of Pegteograstim on Chemotherapy-induced Neutropenia in Children With Solid Tumors
试验速览
- 阶段
- 2 期
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Rate of adverse events
研究概览
简要总结
To evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors
详细描述
Children with solid tumor experience neutropenia after cytotoxic chemotherapy, and they usually receive granulocyte colony-stimulating factor (G-CSF) to stimulate neutrophil recovery. However it needs daily injection of G-CSF. Pegteograstim is a new formulation of PEGylated recombinant human G-CSF analogue pegfilgrastim. In this study, investigators aimed to evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with solid tumor who undergo chemotherapy with carboplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen
排除标准
- •Patients with organ dysfunction (creatinine > 2mg/dL, ejection fraction <40% or severe arrhythmia/conduction disorder, other severe organ dysfunction)
- •Hypersensitivity to pegteograstim, protein originated from E-coli, pegfilgrastim, filgrastim or latex.
- •Patients with bleeding tendency to whom subcutaneous injection should be avoided.
- •Active infection or infectious fever during the screening period.
- •Genetic problem to fructose tolerance.
- •Patients who participated in other clinical trial within 4 weeks before enrollment.
- •Pregnant and nursing women
研究组 & 干预措施
Chemotherapy induced neutropenia
Pegteograstim 100 ug/kg (maximum 6 mg) on day 7 of the chemotherapy cycle
干预措施: Pegteograstim (Drug)
结局指标
主要结局
Rate of adverse events
时间窗: Up to 3 weeks after the injection of pegteograsim
Duration of neutropenia (absolute neutrophil count (ANC) < 500/uL)
时间窗: Up to 6 weeks
次要结局
- Days with neutropenic fever(Up to 6 weeks)
- Lowest value of ANC(Up to 6 weeks)
- Duration of severe neutropenia (ANC < 100/uL)(Up to 6 weeks)