A Single Center Randomized Controlled Trial of the Efficacy and Safety of PEG-rhG-CSF After Autologous Hematopoietic Stem Cell Transplantation for Lymphoma Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Time to neutrophil engraftment
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF on the recovery of hematopoietic function after autologous stem cell transplantation in patients with lymphoma.
详细描述
At present, there is few related research of Recombinant Human Granulocyte Colony-stimulating Factor applying to AHSCT in China. The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF in lymphoma patients after autologous hematopoietic stem cell transplantation. Eligible patients were randomly assigned to PEG-rhG-CSF group or rhG-CSF group. Patients in PEG-rhG-CSF group received PEG-rhG-CSF day +1 after transplantation with a dose of 100μg/kg. Patients with the weight more than 45kg were suggested a dose of 6 mg. Patients in control group received rhG-CSF day +1 after transplantation with a dose of 5μg/kg once per day until the recovery of neutrophil.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with age between 18 and 65 years.
- •Lymphoma patients with the requirement for autologous hematopoietic stem cell transplantation.
- •The collected CD34+ cells≥1×10E6/kg.
- •ECOG score ≤
- •Heart and lung is normal.
- •Blood creatinine ≤1.5×ULN.
- •ALT, AST, TBIL ≤2 ×ULN
- •Not in pregnancy.
- •Written informed consent are acquired.
排除标准
- •Had received autologous hematopoietic stem cell transplantation or allogeneic transplantation.
- •Severe or uncontrolled infectious diseases: HIV, HCV, syphilis, ALT, chronic hepatitis B.
- •Serious complications, such as severe infection, heart, lung, liver and kidney dysfunction.
- •LVEF <55%.
- •Allergic to the product or other biological products from genetically engineered Escherichia coli strains.
- •Refused to take contraceptive measures during the study period and the subsequent 1 years.
- •Severe mental or neurological disorders.
- •Serious heart, lung, central nervous system disorders.
- •Sickle cell anemia, hemolytic anemia and other hematologic diseases.
- •Participate in other drugs clinical trials 30 days before the screening.
- •Other situation that investigators consider as contra-indication for this study.
研究组 & 干预措施
PEG-rhG-CSF
Patients in PEG-rhG-CSF group received PEG-rhG-CSF day +1 after transplantation.
干预措施: PEG-rhG-CSF (Drug)
rhG-CSF
Patients in control group received rhG-CSF day +1 after transplantation.
干预措施: rhG-CSF (Drug)
结局指标
主要结局
Time to neutrophil engraftment
时间窗: 30days
次要结局
未报告次要终点
研究者
Jun Zhu
Director
Peking University