Safety and Efficacy of Pegylated Recombinant Human Granulocyte-colony Stimulating Factor(PEG-rhG-CSF) in Preventing Neutropenia in Children With Tumor After Chemotherapy：A Multi-center, Single Arm Trial.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- safety of PEG-rhG-CSF in the prevention of neutropenia in children with tumor after chemotherapy
研究概览
简要总结
The purpose is to evaluate the safety of PEG-rhG-CSF in the prevention of neutropenia in children with tumor after chemotherapy, and then evaluate the effectiveness of PEG-rhG-CSF in preventing neutropenia in children with tumor after chemotherapy.
详细描述
The dosage was determined according to the patient's weight, 100 UG / kg each time; The method of administration: subcutaneous injection; The time of administration: 24-48 hours after the end of chemotherapy, once in each chemotherapy cycle.
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6 years < age < 18 years old, regardless of gender; 2)Tumor patients diagnosed by histopathology or bone marrow cytology; 3)Patients who have not been treated for the first time; 4)ECoG score ≤ 2; 5)The expected survival time is more than 8 months; 6)The hematopoietic function of bone marrow was normal (ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L, Hb ≥ 75 g / L, WBC ≥ 3.0 × 109 / L); 7)Receive high-intensity chemotherapy, such as scccg lymphoma, CAV / ie, VIP regimen, etc., and expect bone marrow suppression of grade III or above after chemotherapy.
- •Patient's parent or guardian signs informed consent.
排除标准
- •Patients with any of the following items will not be enrolled in this study:
- •Local or systemic infection without adequate control;
- •Severe visceral dysfunction;
- •Liver function test: total bilirubin (TBIL), alanine aminotransferase (ALT), aspartate aminotransferase (AST) were all higher than 2.5 times of the upper limit of normal value; if due to liver metastasis, the above indicators were more than 5 times of the upper limit of normal value; renal function test: Serum creatinine (CR) > 2 times of the upper limit of normal value;
- •Those who took the same kind of other tested drugs or accepted clinical trials of other drugs within 4 weeks before enrollment;
- •Allergic to peg-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli;
- •Serious mental illness, affecting informed consent and / or expression or observation of adverse reactions;
- •The researcher judged the patients who were not suitable to participate.
研究组 & 干预措施
PEG-rhG-CSF
pegylated recombinant human granulocyte-colony stimulating factor subcutaneous injection
干预措施: pegylated recombinant human granulocyte-colony stimulating factor (Drug)
结局指标
主要结局
safety of PEG-rhG-CSF in the prevention of neutropenia in children with tumor after chemotherapy
时间窗: From the beginning of observation to the end of observation（6 weeks) of the last enrolled patient
The incidence and severity of adverse events;
次要结局
- To evaluate the effectiveness of PEG-rhG-CSF in preventing neutropenia in children with tumor after chemotherapy.(From the beginning of observation to the end of observation（6 weeks) of the last enrolled patient)
研究者
Yizhuo Zhang
Sun Yat-sen University Cancer Center
Sun Yat-sen University