NCT05834751尚未招募不适用
Clinical Study on the Effectiveness and Safety of Pegylated Recombinant Human Granulocyte Stimulating Factor Injection and PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells in Lymphoma.
Ou Bai, MD/PHD1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2023年5月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Mobilization success rate
研究概览
简要总结
A single center, non-inferiority, two-way cohort clinical study to evaluate the efficacy and safety of pegylated recombinant human granulocyte stimulating factor injection in the mobilization of autologous hematopoietic stem cells in lymphoma.
详细描述
The objective was to to evaluate the efficacy and safety of pegylated recombinant human granulocyte stimulating factor injection in the mobilization of autologous hematopoietic stem cells in lymphoma.
lymphoma patients who need to be prepared for autologous hematopoietic stem cell transplantation; KPS score ≥70; Ccr≥ 50 mL/min, TBIL< 25.65 umol/L, ALT and AST < 2 times the upper limit of normal value;
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Age 18-65 years old, regardless of gender;
- •lymphoma patients who need to be prepared for autologous hematopoietic stem cell transplantation;
- •KPS score ≥70;
- •Ccr≥ 50 mL/min, TBIL< 25.65 umol/L, ALT and AST < 2 times the upper limit of normal value;
- •ANC ≥ 1.5×109/L，PLT ≥ 80×109/L，Hb ≥ 75g/L，WBC ≥ 3.0×109/L；
- •Patients can tolerate chemotherapy；
- •No active infection before chemotherapy;
- •The retrospective enrolled subjects are exempted from informed consent for data collection, and the prospective enrolled subjects voluntarily participate in this experiment and sign the informed consent form;
- •The researcher thinks that the subjects can benefit.
排除标准
- •Patients with megaspleen (when inhaling deeply, the spleen exceeds the right umbilicus and/or below the umbilical level);
- •Those who have received mobilization and transplantation of allogeneic or autologous hematopoietic stem cells before;
- •Subjects who have evidence of serious or uncontrollable systemic diseases (such as unstable or irreparable respiratory, heart, liver or kidney diseases) according to the researcher's judgment;
- •severe mental or nervous system diseases;
- •Those who are allergic to PEG-rhG-CSF, rhG-CSF and any active ingredients or auxiliary materials of other preparations expressed by Escherichia coli, or have a clear history of protein drug allergy, specific allergic reaction (asthma, rheumatism, eczema dermatitis) or have had other serious allergic reactions;
- •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
PEG-rhG-CSF
干预措施: PEG-rhG-CSF (Drug)
control group
Active Comparator
rhG-CSF
干预措施: RhG-CSF (Drug)
结局指标
主要结局
Mobilization success rate
时间窗: 48 months
Accumulate CD34+cells ≥ 2×106/kg for 3 times or less
次要结局
- Acquisition times(30 days)
- Speed of recovery(30 days)
- Time of highest point of CD34+ cells(30 days)
- Single acquisition volume(30 days)
- White blood cell trough and peak(30 days)
- Administration times of rhG-CSF(30 days)
研究者
Ou Bai, MD/PHD
Director
The First Hospital of Jilin University
研究点 (1)
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