G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor: a Prospective, Multicentre, Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 405
- 试验地点
- 7
- 主要终点
- assess the incidence of infection in patients after chemotherapy
研究概览
简要总结
The purpose of this study is to explore the effect of G-CSF combination with GM-CSF on prevention and treatment of infection in children with malignant tumor.
详细描述
G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor.
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
- •Patients with malignant tumor including acute myeloid leukemia (AML) after complete remission, acute lymphocytic leukemia (ALL) after complete remission, stage III or IV lymphoma after partial remission or complete remission, stage III or IV neuroblastoma (NB) or retinoblastoma (RB).
- •Eastern Cooperative Oncology Group performance status ≤
- •Did not receive treatment of CSFs in two weeks.
- •Without symptomatic infection and with normal values of C-reactive protein or procalcitonin.
- •The first time of ANC < 1.5*10^9/L after chemotherapy.
- •More than 24 h after the last chemotherapy.
- •The function of liver was normal.
排除标准
- •Allergic to GM-CSF or drugs which expressed in Escherichia coli.
- •Patients with infection, diabetes or primary immunodeficiency.
- •Patients infected with hepatitis B, hepatitis C or HIV.
- •Patients confirmed autoimmune thrombocytopenic purpura.
研究组 & 干预措施
G-CSF
Eligible patients received subcutaneous G-CSF 5 μg/kg per day when the first time of absolute neutrophil count [ANC] <1.5*10^9/L after chemotherapy. G-CSF is given daily for at least 5 days and continued until the ANC reached 1.5*10^9/L for two consecutive days.
干预措施: G-CSF (Biological)
G-CSF + GM-CSF
Eligible patients received subcutaneous a combination of GM-CSF 5 μg/kg per day and G-CSF 5 μg/kg per day when the first time of absolute neutrophil count [ANC] <1.5*10^9/L after chemotherapy. GM-CSF and G-CSF are given daily for at least 5 days and continued until the ANC reached 1.5*10^9/L for two consecutive days.
干预措施: GM-CSF and G-CSF (Biological)
GM-CSF
Eligible patients received subcutaneous GM-CSF 5 μg/kg per day when the first time of absolute neutrophil count [ANC] <1.5*10^9/L after chemotherapy. GM-CSF is given daily for at least 5 days and continued until the ANC reached 1.5*10^9/L for two consecutive days.
干预措施: GM-CSF (Biological)
结局指标
主要结局
assess the incidence of infection in patients after chemotherapy
时间窗: within 20 days after chemotherapy
次要结局
未报告次要终点
研究者
Xiaojun Yuan
chief physician
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine