NCT06026995招募中4 期
Clinical Study on the Effectiveness and Safety of PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells for Lymphoma and Multiple Myeloma
Chongqing University Cancer Hospital1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2022年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- The proportion of patients with CD34+ cells ≥2×106/kg
研究概览
简要总结
This study is a randomized controlled, open and multi-center clinical study. Patients who meet the selection criteria and do not meet the exclusion criteria are randomly given PEG-rhG-CSF with a fixed dose of 12mg when white blood cells reach the lowest point, or given rhG-CSF with a daily mobilization of 5-10μ g/kg until the collection is completed, so as to evaluate the effectiveness and safety of PEG-rhG-CSF in mobilizing autologous stem cells for lymphoma and multiple myeloma.
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
- •18-65 years old, regardless of sex;
- •Patients with lymphoma and multiple myeloma who need autologous hematopoietic stem cell transplantation;
- •KPS score ≥70;
- •creatinine clearance rate ≥ 50mL/min, total bilirubin level < 1.5mg/dL, ALT and AST < 2 times the upper limit of normal value;
- •Absolute neutrophil count (ANC)≥1.5×109/L, platelet count ≥80×109/L, Hb≥ 75g/L, WBC ≥ 3.0× 109/L;
- •Patients can tolerate chemotherapy;
- •No active infection before chemotherapy;
- •The patient voluntarily participated in this trial and signed the informed consent form;
- •The researcher thinks that the subjects can benefit.
排除标准
- •Those who have previously received allogeneic or autologous hematopoietic stem cell transplantation;
- •Serious or uncontrolled virus infection: HIV, syphilis positive;
- •Severe dysfunction of internal organs;
- •severe mental or nervous system diseases;
- •allergic to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed in Escherichia coli;
- •pregnant or lactating female patients; Women of childbearing age refuse to accept contraceptive measures; Those who plan to become pregnant during the study period;
- •The researcher judges other subjects who are not suitable to participate.
研究组 & 干预措施
experimental group
Experimental
干预措施: PEG-rhG-CSF (Drug)
control group
Active Comparator
干预措施: RhG-CSF (Drug)
结局指标
主要结局
The proportion of patients with CD34+ cells ≥2×106/kg
时间窗: 28 days
The proportion of patients with CD34+ cells ≥2×106/kg
次要结局
- Mobilization time(28 days)
- Hematopoietic reconstruction time after transplantation(3 months)
- Acquisition times(28 days)
- complication(3 months)
- CD34+cell count(28 days)
研究者
Yao Liu
Director
Chongqing University Cancer Hospital
研究点 (1)
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