Quantification of the Time and Effort Required for Peripheral Blood Stem Cell Collection - The European Perspective
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 248
- 主要终点
- Type, duration and length of administration of mobilizing agents
研究概览
简要总结
This study aims to observe the effects of the availability of plerixafor on the time and effort associated with autologous peripheral blood stem cell collection.
详细描述
This non interventional study will consist of two parts:
I. Retrospective study:
A medical record review will be conducted covering 200 patients file undergoing peripheral blood stem cell mobilization in some European centers.
II. Prospective study :Time/Motion evaluation of actual apheresis - 20 events each center The actual apheresis events will be measured in consecutive patients scheduled to be candidates for peripheral blood stem mobilization in the apheresis area of the hospital. Each apheresis will be considered as one event . Should the patient receive more than 1 apheresis, each apheresis will be considered as one different event.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must satisfy the following for the part 1
- •Oncology patients diagnosed with Non-Hodgkin lymphoma who are candidates for autologous hematopoietic stem cell transplantation (HSCT)
- •A patient that fails to achieve a target CD34+>20 cells/µl, before or on the first day of apheresis
- •Age > 18 years
- •Exclusion Criteria for the part 1
- •Patients with:
- •Age < 18 years;
- •Primary diagnosis other than Non-Hodgkin lymphoma
- •Undergone prior autologous hematopoietic stem cell transplantation (HSCT)
排除标准
- 未提供
结局指标
主要结局
Type, duration and length of administration of mobilizing agents
时间窗: one week
Number of visits for administration of mobilizing agents Duration (days) of administration of mobilizing agents Type of agents used as mobilizing agents
Number and length of apheresis sessions and number of collected stem cells
时间窗: one week
Number of apheresis sessions Number of hours of apheresis sessions Attainment of CD34+ cells target (yes, no) Number of days until CD34+ target level is met
次要结局
未报告次要终点
研究者
Pr Mohamad MOHTY
Professor
Association for Training, Education, and Research in Hematology, Immunology, and Transplantation