A Phase II Single Institution Randomized Study Comparing Cytokine Administration Sites for Mobilization of Peripheral Hematopoietic Progenitor Cells for Patients Undergoing Autologous Hematopoietic Progenitor Cell Transplant
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- The Total Number of CD34+ Cells Collected.
研究概览
简要总结
The purpose of this study is to determine whether or not the injection site of cytokines, or growth factors, has an effect on peripheral blood stem cell collection.
详细描述
The purpose of this study is to determine the preferred injection site for G-CSF and GM-CSF, which are cytokines, or growth factors. The doctor may also choose to use these growth factors in combination with chemotherapy to increase the number of stem cells in the blood. Both options are established and are effective in increasing the number of stem cells in the blood.
Patients will receive one shot under the skin twice a day for approximately 12-15 days after receiving chemotherapy through the time your cells are being collected. Patients will be randomly assigned to receive growth factors administered either to their abdomen or to their extremities. Both shots will always be given either in the abdomen or in the extremities.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing autologous peripheral blood stem cell transplant (PBSC) for relapsed/refractory Hodgkin's disease, non-Hodgkin's lymphoma, or patients with myeloma. All patients must meet criteria for transplantation.
排除标准
- •Patients with active, invasive/systemic fungal infection.
- •Patients who are pregnant or lactating females.
- •Patients with active CNS malignant disease or life expectancy limited by diseases other than the disease for which the patient is being transplanted.
- •Also, patients cannot have known hypersensitivity to either G-CSF or GM-CSF.
研究组 & 干预措施
Abdomen
These subjects will have their cytokine injections administered only to their abdomen.
干预措施: G-CSF and GMCSF administered at abdomen (Drug)
Extremities
The extremity arm will have their injections administered to their upper and/or lower extremities.
干预措施: G-CSF, GM-CSF administered at extremities (Drug)
结局指标
主要结局
The Total Number of CD34+ Cells Collected.
时间窗: 4 days
Number of Participants for Whom Target Number of CD34+ Cells Were Collected.
时间窗: 7 days
Target numbers of CD34+ cells for a single autologous transplant are typically at least 5.0 \* 10\^6 cells/kg, a cell dose that consistently results in rapid cell engraftment
次要结局
- Total Number of Days of Apheresis(7 days)
研究者
Edmund Waller
Principal Investigator
Emory University