Pegfilgrastim Versus Filgrastim - Intraindividual Comparison of Quantity and Quality of Mobilized Peripheral Blood Stem Cells in Patients With Non Hodgkin-lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Hematopoietic recovery after autologous stem cell transplantation
研究概览
简要总结
The purpose of this study is to compare the ability of pegfilgrastim vs. filgrastim to mobilize peripheral blood stem cells in patients with Non Hodgkin-lymphoma in an intraindividual study
详细描述
Patients with Non Hodgkin-lymphoma undergoing stem cell mobilization for planned high-dose therapy will be treated with two cycles of chemotherapy (etoposide, ifosfamide, cisplatin, epirubicin), either followed by daily administration of filgrastim (first cycle) or pegfilgrastim (once after the second cycle). The number of circulating cluster of differentiation 34+ cells, colony-forming units and primitive progenitors will be analyzed at corresponding time points. Peripheral blood stem cells will be collected after the second cycle of chemotherapy by leukapheresis. After the second cycle, high-dose therapy with peripheral blood stem cell support will be administered (the protocol will be chosen according to the diagnosis, including total body irradiation-containing regimens).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •histological diagnosis of non-Hodgkin lymphoma
- •planned high-dose therapy with autologous stem cell transplantation
- •WHO performance status 0-2
- •written consent
排除标准
- •allergy against (peg)filgrastim
- •life expectancy <3 months
- •other malignant diseases within the last 5 years
- •cardial insufficiency (>= New York Heart Association II°)
- •uncontrolled infection
- •pregnancy, lactation
- •central nervous system lymphoma
- •Karnofsky score <70%
研究组 & 干预措施
Pegfilgrastim
Pegfilgrastim for stem cell mobilization (single arm)
干预措施: pegfilgrastim (Drug)
结局指标
主要结局
Hematopoietic recovery after autologous stem cell transplantation
时间窗: 1-3 weeks after transplantation, follow up every 3 months (up to 2 years)
Two cycles of conventional chemotherapy are given. Starting one day after the first cycle, filgrastim (5ug/kg bodyweight daily subcutaneously) is routinely administered to support neutrophil recovery. One day after the second cycle, a single dose of pegfilgrastim (6mg) is given to support neutrophil recovery and stem cell collection. Hematopoietic recovery (blood count) is monitored daily after high-dose therapy and autologous stem cell transplantation. Follow up assessments are performed 3-monthly for late graft failure
次要结局
- Intraindividual comparison of quantity/quality of circulating stem cells(before and during 3 weeks after conventional chemotherapy)
研究者
Prof. Dr. med. Wolfgang Bethge
Oberarzt
University Hospital Tuebingen