Open Label Phase II Trial of an Augmented Mobilization Strategy With Plerixafor (Mozobil®) in a Population at Risk for Poor Stem Cell Mobilization
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- To increase the proportion of Poor Mobilizers who after receiving plerixafor are successfully collected in one day. The anticipated proportion increase is from 30%-60%.
研究概览
简要总结
Poor mobilization of hematopoietic progenitors needed to support autologous transplantation is a serious clinical problem. We are investigating the role of plerixafor administered in an at risk population to augment successful stem cell collection.
OBJECTIVES
To determine if plerixafor when administered on the day prior to planned autologous collection on first mobilization attempt in those with a peripheral blood CD34 ≤ 10X106/L will:
- increase the number of patients successfully collected in one day
- increase the number of patients successfully mobilized on first collection attempt
- is cost neutral within a Canadian setting
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Participants must be 18 years of age or older
- •Patients must be able to provide written consent
- •Participants must have a diagnosis of lymphoma or multiple myeloma and be undergoing autologous stem cell mobilization for the purposes of ASCT
- •Females of child bearing age will be asked to use an approved form of contraception
排除标准
- •Patients who are pregnant or breastfeeding
- •Patients whose creatinine ≥ 250 μM
- •Serum AST, ALT or total bilirubin >5X upper limit of normal
- •Acute infection
研究组 & 干预措施
Poor Mobilizers
Poor Mobilizer are defined as patients who on Day -1 have a peripheral blood [CD34] ≤ 10 X106/L
干预措施: Plerixafor (Drug)
结局指标
主要结局
To increase the proportion of Poor Mobilizers who after receiving plerixafor are successfully collected in one day. The anticipated proportion increase is from 30%-60%.
时间窗: within 1-2 days after commencing therapy
次要结局
- To examine the immune recovery at day 100 post ASCT in those treated and not treated with plerixafor(After therapy)
- To undertake a pharmacoeconomic evaluation to examine the impact of plerixafor on resource utilization in a population at risk for poor mobilization(After therapy)
- To increase the proportion of Poor Mobilizers who after receiving plerixafor are successfully collected on first mobilization attempt rather than requiring a second mobilization.(After therapy)
- To describe the kinetics of platelet and neutrophil recovery post ASCT in those treated and not treated with plerixafor(After therapy)
研究者
Dr. David Szwajcer
Hematologist/Oncologist
CancerCare Manitoba