Efficacy of Generic Pegfilgrastim vs Brand Name Pegfilgrastim for Neutrophil Recovery After Autologous Stem Cell Transplant
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Time to neutrophil recovery
研究概览
简要总结
This is a phase 2 clinical trial comparing time to neutrophil recovery after autotrasplant using generic pegfilgrastim vs brand-name pegfilgrastim.
详细描述
Thirty consecutive adults with lymphoma or myeloma receiving autologous peripheral blood stem cell transplant will be included in this phase 2 clinical trial. Patients will be allocated 1:1 in two groups: one subcutaneous 6 mg dose of generic pegfilgrastim (control group) or one 6mg dose of brand-name pegfilgrastim (intervention group) both at day +1 after the autotransplant. Daily complete blood counts were collected and time to neutrophil (>0.5x10^3/microL) and platelet recovery (>20x10^3/microL) will be obtained. The investigators will describe the proportion of adverse events and median time to neutrophil and platelet recoveries. Median or mean time to neutrophil recovery and time to platelet recovery will be calculated and compared with Mann-Whitney-Wilcoxon test or student T.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing autologous peripheral blood stem cell transplantation
- •Patients with multiple myeloma or lymphoma
- •Adults (>18 years)
- •Both genders
- •Eastern Cooperative Oncology Group (ECOG) <=2
排除标准
- •Alanine Aminotransferase or bilirubin values >2.5 times the superior normal limit
- •Creatinin >2.2mg/dL
- •Fever >37.6°C
- •Active infection
- •Hepatitis B, C or HIV infection
- •Congestive heart failure (ejection fraction <40%)
研究组 & 干预措施
Generic pegfilgrastim
One 6mg subcutaneous dose of generic pegfilgrastim in day+1 after autotransplant
干预措施: Pegfilgrastim (Drug)
Brand name pegfilgrastim
One 6mg subcutaneous dose of brand name pegfilgrastim in day+1 after autotransplant
干预措施: Pegfilgrastim (Drug)
结局指标
主要结局
Time to neutrophil recovery
时间窗: 15 days
Time from autologous transplant to neutrophil count \>0.5x10\^3/microL
次要结局
- Time to platelet recovery(15 days)
研究者
Cesar Homero Gutierrez-Aguirre
Clinical Professor
Hospital Universitario Dr. Jose E. Gonzalez