A Randomized,Open-label Dose-discovery Study of PEG-rhG-CSF and rhG-CSF in the Adjuvant Therapy of Aplastic Anemia Granulocyte Deficiency
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- total number of effective (ANC>0.5×109/L) days
研究概览
简要总结
This study was a single-center,open-label,randomized,dose-exploring prospective study.Patients with granulocytotic aplastic anemia who received cytokine treatment with PEG-rhG-CSF or rhG-CSF were enrolled.Clinical demographic data,disease characteristics of aplastic anemia,clinical diagnosis and treatment,laboratory data and adverse events were collected to explore the dose and safety of PEG-rhG-CSF and rhG-CSF in patients with severe aplastic anemia.
详细描述
This study was a single-center,open-label,randomized,dose-exploring prospective study.Patients with granulocytotic aplastic anemia who received cytokine treatment with PEG-rhG-CSF or rhG-CSF were enrolled.Clinical demographic data,disease characteristics of aplastic anemia,clinical diagnosis and treatment,laboratory data and adverse events were collected to explore the dose and safety of PEG-rhG-CSF and rhG-CSF in patients with severe aplastic anemia.Research objectives: To explore the reasonable injection frequency of long-acting PEG-rhG-CSF in the adjuvant treatment of aplastic anemia patients with granulocytosis through a single center prospective clinical study.Disease classification of aplastic anemia: a total of 45 cases of SAA/VSAA with ANC<0.5×109/L were stratified and randomized into three groups according to the radio of 1:1:1(15 cases in each group).PEG-rhG-CSF group A(q7d):6mg d1,8,subcutaneously injected;PEG-rhG-CSF group B(q10d):6mg d1,11,subcutaneously injected;RhG-CSF group(short-acting ): 480ug d1-14(daily for 14days),subcutaneously injected.Dose/protocol adjustment: after monitoring ANC>0.5×109/L,the drug was stopped,and then ANC<0.5×109/L was temporarily supplemented with one dose of the original group of drugs.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years old, male or female, or weight≥50kg.
- •Patients with severe or very severe aplastic anemia of absolute neutrophil value< 0.5×109/L
- •ECOG score ≤ 2 points.
- •Normal renal function.
排除标准
- •Patients with clonal chromosomal abnormalities.
- •Patients with previous malignant tumors.
- •Patients with severe or uncontrolled infectious diseases and /or bleeding.
- •Patients with AIDS or syphilis positive.
- •Severe organ dysfunction.
- •Patients used GM/G-CSF,PEG-rhG-CSF,interleukin-11 within 2 weeks before admission.
- •Allergic to G-CSF or PEG-rhG-CSF related components.
- •Participated in other clinical trials within 6 months.
研究组 & 干预措施
PEG-rhG-CSF group A
PEG-rhG-CSF group A(q7d):6mg d1,8,subcutaneously injected,after monitoring ANC>0.5×109/L,the drug was stopped,and then ANC<0.5×109/L was temporarily supplemented with one dose of the same drug.
干预措施: PEG-rhG-CSF (Drug)
PEG-rhG-CSF group B
PEG-rhG-CSF group B(q10d):6mg d1,11,subcutaneously injected,after monitoring ANC>0.5×109/L,the drug was stopped,and then ANC<0.5×109/L was temporarily supplemented with one dose of the same drug.
干预措施: PEG-rhG-CSF (Drug)
rhG-CSF group(short-acting )
rhG-CSF group(short-acting ): 480ug d1-14(daily for 14days),subcutaneously injected.After monitoring ANC>0.5×109/L,the drug was stopped,and then ANC<0.5×109/L was temporarily supplemented with one dose of the same drug.
干预措施: PEG-rhG-CSF (Drug)
结局指标
主要结局
total number of effective (ANC>0.5×109/L) days
时间窗: 2 weeks
total number of effective (ANC\>0.5×109/L) days during 2 weeks of treatment(cases×days).
次要结局
未报告次要终点