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临床试验/NCT01700608
NCT01700608已完成不适用

Prospective Observational Study on Plerixafor After Chemotherapy

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
27
试验地点
1
主要终点
Number of patients who were able to collect >= 2 x 10^6 CD34+/kg

研究概览

简要总结

Plerixafor is a new CXCR4 inhibitor that is able to improve peripheral blood stem cell (PBSC) mobilization when combined with granulocyte-colony-stimulating factor (G-CSF). The 'on demand' use of plerixafor at the hematopoietic recovery after chemotherapy + G-CSF may be more efficient and cost-effective, but the timing of administration and criteria for patient selection are still under investigation. We collected the data of lymphoma and myeloma patients treated with plerixafor at the hematopoietic recovery after chemotherapy + G-CSF. The decision of adding plerixafor was based on PB CD34+ cells at the time of hematopoietic recovery after chemotherapy in patients at their first or subsequent attempt, according to the attending physician choice. The primary endpoint was the assessment of the rate of patients who were able to collect >=2 x 10^6 CD34+/kg.

详细描述

Plerixafor is a new CXCR4 inhibitor that is able to improve peripheral blood stem cell (PBSC) mobilization when combined with granulocyte-colony-stimulating factor (G-CSF). The 'on demand' use of plerixafor at the hematopoietic recovery after chemotherapy + G-CSF may be more efficient and cost-effective, but the timing of administration and criteria for patient selection are still under investigation. We collected the data of lymphoma and myeloma patients treated with plerixafor at the hematopoietic recovery after chemotherapy + G-CSF. The decision of adding plerixafor was based on PB CD34+ cells at the time of hematopoietic recovery after chemotherapy in patients at their first or subsequent attempt, according to the attending physician choice. The primary endpoint was the assessment of the rate of patients who were able to collect >=2 x 10^6 CD34+/kg. Secondary endpoint was the assessment of the rate of patients collecting > 4 x 10^6 CD34+/kg and the median number of apheresis to reach the target.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • lymphoma and myeloma patients treated with plerixafor at the hematopoietic recovery after chemotherapy and G-CSF

排除标准

  • patients treated only with G-CSF and plerixafor without chemotherapy

研究组 & 干预措施

plerixafor treated patients

lymphoma and myeloma patients

干预措施: plerixafor (Drug)

结局指标

主要结局

Number of patients who were able to collect >= 2 x 10^6 CD34+/kg

时间窗: From day 1 to day 25 after mobilizing chemotherapy

次要结局

  • Number of patients who were able to collect > 4 x 10^6 CD34+/kg.(From day 1 to day 25 after mobilizing chemotherapy)

研究者

发起方
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paolo Corradini

Professor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

研究点 (1)

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