A Multi-center, Open, Randomized, Controlled Clinical Study of Autologous Peripheral Blood Stem Cell Mobilization for Pegylated Recombinant Human Granulocyte Colony Stimulating Factor
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Efficiency of stem cell mobilization
研究概览
简要总结
Have a comparison between pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF) and recombinant human granulocyte-colony stimulating factor (rhG-CSF) for difference in efficacy of hematopoietic reconstruction after autologous peripheral blood stem cell mobilization (PBSCM) and autologous peripheral blood stem cell transplantation (APBSCT).
Primary purpose:
Compare the difference between PEG-rhG-CSF and G-CSF in PBSCM.
Secondary purpose:
Compare the difference between PEG-rhG-CSF and G-CSF in APBSCT.
详细描述
Key issues to be addressed:
To compare the efficiency of stem cell mobilization and hematopoietic system reconstruction between PEG-rhG-CSF and rrhG-CSF.
Research design:
A multicenter, open, prospective randomized controlled clinical study.
Research objects:
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed as hematological diseases definitely, body weight ≥30kg, age: 18-60 years, without limitation in gender or race;
- •Patients who receive APBSCT voluntarily;
- •Patients who participate in the open randomized controlled study of autologous hematopoietic stem cell mobilization for PEG-rhG-CSF and G-CSF voluntarily;
- •Each subject must sign the informed consent from (ICF) to indicate that he/she understands the purposes and procedures of the study, and participates in the study voluntarily. Considering the patient's conditions, if the patient's signature is not conducive to treatment, his/her legal representative will sign the ICF.
排除标准
- •Patients who have serious organ dysfunctions or diseases, such as serious diseases or dysfunctions heart, liver, kidney, pancreas and etc.;
- •Patients who cannot tolerate autologous hematopoietic stem cell transplantation and autologous stem cell mobilization;
- •Subjects who and/or whose authorized family members refuse HSCT or PEG-rhG-CSF treatment;
- •Subjects with any life-threatening disease, medical condition or organ system dysfunction compromising their safety or causing unnecessary risks for the study results in the investigator' opinion, with drug dependence, with uncontrolled mental illness, or with cognitive dysfunction;
- •Subjects who participate in other similar clinical studies within 3 months;
- •Subjects who are considered as unsuitable for the study by the investigator (e.g., those expected to be unable to adhere to relevant treatment regimen due to financial problems).
研究组 & 干预措施
PEG-G-CSF
6 mg, single dose
干预措施: PEG-rhG-CSF (Drug)
rhG-CSF
5 μg/kg, twice a day
干预措施: PEG-rhG-CSF (Drug)
结局指标
主要结局
Efficiency of stem cell mobilization
时间窗: 3years
Count of collected CD34+ cells (CD34+ \> 2×10\^6 /kg will be considered as successful mobilization).
次要结局
- Time of hematopoietic reconstitution(3years)
研究者
Ning Huang
professor
Qianfoshan Hospital