Non-interventional, Prospective, Long-term Safety Data Collection of Zarzio® / Filgrastim HEXAL® in Healthy Unrelated Stem Cell Donors Undergoing Peripheral Blood Progenitor Cell Mobilization
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Sandoz
- 入组人数
- 245
- 试验地点
- 2
- 主要终点
- Incidence of drug-related adverse events following mobilization with Sandoz' filgrastim.
研究概览
简要总结
Data collection on the safety and efficacy of Zarzio® / Filgrastim HEXAL® in adult healthy unrelated stem cell donors undergoing peripheral blood progenitor cell mobilization.
详细描述
This will be a prospective, non-interventional long term data collection study. Adult healthy unrelated stem cell donors receiving Sandoz' filgrastim according to the stem cell mobilization protocols of the respective apheresis centers will be monitored for safety and efficacy during the mobilization period, and a systematic safety data follow-up will be implemented for up to 10 years after mobilization.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteer adult healthy unrelated donors who have received at least one dose of Sandoz' filgrastim for PBPC mobilization
排除标准
- •Donors of age <18 years
- •Related to recipient
- •Chronic significant organ diseases
- •Systemic autoimmune diseases
- •Chronic infectious diseases
- •History of malignant disease
- •Pregnant and breastfeeding women
- •Hypersensitivity to E. coli derived proteins
- •Hypersensitivity to the active substance or to any of the excipients of Sandoz' filgrastim
- •Absolute and relative contraindications as specified in the SmPC of Sandoz' filgrastim
- •Participation in previous stem cell mobilization procedures
- •Previous or concurrent use of other mobilizing agents, e.g. plerixafor
- •Informed consent was not signed prior to beginning of documentation.
结局指标
主要结局
Incidence of drug-related adverse events following mobilization with Sandoz' filgrastim.
时间窗: each patient will be followed for 10 years after mobilization
The primary objective is to investigate adverse events that are suspected to be related to stem cell mobilization with the Sandoz' filgrastim in healthy unrelated donors.
次要结局
- Efficacy assessment in terms of the CD34+ cell count.(CD34+ cells are counted on 1 day immediately preceding apheresis)