A Multi-center, Open-label, Randomized Controlled Study to Evaluate the Efficacy and Safety of the Prophylactic Use of Pegylated Recombinant Human Granulocyte Colony Stimulating Factor After Chemotherapy in Children With Hematological Malignancies
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Incidence of febrile neutropenia (FN)
研究概览
简要总结
The incidence of infectious complications in hematological malignancies is higher than that in children with solid tumors, which may be related to the type and dose intensity of chemotherapy regimens used in hematological tumors. The treatment of childhood cancer has changed in the past few decades: intensive treatment and good supportive treatment can improve the 5-year survival rate of children. The aim of this study was to evaluate the efficacy and safety of prophylactic use of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) after chemotherapy in children with hematological malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Under the age of 18, no gender limit;
- •Children with hematological malignancies, leukemia or lymphoma, diagnosed by bone marrow pathology or cytology;
- •The prophylactic use of PEG-rhG-CSF or rhG-CSF after chemotherapy is intended to prevent neutropenia, and the chemotherapy regimen must meet the interval between two chemotherapy sessions at least 12 days;
- •The effect of chemotherapy in leukemia patients was complete remission, while that in lymphoma patients was complete remission or partial remission;
- •The expected survival time is more than 8 months;
- •Liver and kidney function: Liver function: total bilirubin (TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal value, or≤5 times the upper limit of normal value when there is liver metastasis; renal function test: serum creatinine (Cr) ≤ 1.5 times the upper limit of normal value;
- •Eastern Cooperative Oncology Group(ECOG) performance status(PS) <2;
- •The subjects had good mental consciousness, and the subject's legal guardian must sign an informed consent form;
- •Researchers believe that the subject can benefit;
排除标准
- •Severe internal organ dysfunction;
- •Those who used other test drugs of the same kind or accepted other clinical trials within 4 weeks before enrollment;
- •Allergy to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli;
- •Researchers determine unsuited to participate in this trial.
研究组 & 干预措施
PEG-rhG-CSF group
Patients received subcutaneous injection of PEG-rhG-CSF(Jinyouli®)24~72 hours after the end of chemotherapy, 100µg/kg, once in each chemotherapy cycle.
干预措施: PEG-rhG-CSF group (Drug)
rhG-CSF group
Patients received subcutaneous injection of rhG-CSF 24~72 hours after the end of chemotherapy, 100µg/kg/d, and stop using it until the ANC value exceeds the lowest value for 2 consecutive days> 0.5×10^9/L.
干预措施: rhG-CSF group (Drug)
结局指标
主要结局
Incidence of febrile neutropenia (FN)
时间窗: From date of randomization until the date of the study completion, up to 24 weeks.
ANC\<0.5×10\^9/L or ANC (0.5-0.9)×10\^9/L, and predicted to drop to ≤0.5×10\^9/L in the next 48 hours, and the oral cavity temperature is ≥38.3℃ or ≥38.0℃ for more than 1 hour.
次要结局
- Duration of febrile neutropenia(From date of randomization until the date of the study completion, up to 24 weeks.)
- Dynamic curve of absolute neutrophil count (ANC)(From date of randomization until the date of the study completion, up to 24 weeks.)
- Incidence of infection(From date of randomization until the date of the study completion, up to 24 weeks.)
- Dose adjustment of chemotherapy or delay of chemotherapy(From date of randomization until the date of the study completion, up to 24 weeks.)
- Incidence and duration of grade IV neutropenia (ANC<0.5×10^9/L)(From date of randomization until the date of the study completion, up to 24 weeks.)
- Recovery time of grade IV neutropenia(From date of randomization until the date of the study completion, up to 24 weeks.)
- Hospital stay(From date of randomization until the date of the study completion, up to 24 weeks.)