Prospective Observational Study on Plerixafor After Chemotherapy
2012年10月2日 更新者:Paolo Corradini、Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (实际的)
27
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
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Milan、意大利、20133
- Fondazione IRCCS Istituto Nazionale dei Tumori
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
lymphoma and myeloma patients treated with plerixafor at the hematopoietic recovery after chemotherapy and G-CSF
描述
Inclusion Criteria:
- lymphoma and myeloma patients treated with plerixafor at the hematopoietic recovery after chemotherapy and G-CSF
Exclusion Criteria:
- patients treated only with G-CSF and plerixafor without chemotherapy
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 观测模型:仅案例
- 时间观点:预期
队列和干预
团体/队列 |
干预/治疗 |
---|---|
plerixafor treated patients
lymphoma and myeloma patients
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plerixafor 240 mcg/kg/day at the hematopoietic recovery after chemotherapy
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Number of patients who were able to collect >= 2 x 10^6 CD34+/kg
大体时间:From day 1 to day 25 after mobilizing chemotherapy
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From day 1 to day 25 after mobilizing chemotherapy
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次要结果测量
结果测量 |
大体时间 |
---|---|
Number of patients who were able to collect > 4 x 10^6 CD34+/kg.
大体时间:From day 1 to day 25 after mobilizing chemotherapy
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From day 1 to day 25 after mobilizing chemotherapy
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其他结果措施
结果测量 |
大体时间 |
---|---|
To determine the median number of apheresis to reach >= 2-4 x 10^6 CD34+/kg
大体时间:From day 1 to day 25 after mobilizing chemotherapy
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From day 1 to day 25 after mobilizing chemotherapy
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Paolo Corradini, MD、Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年9月1日
初级完成 (实际的)
2012年4月1日
研究完成 (实际的)
2012年4月1日
研究注册日期
首次提交
2012年10月1日
首先提交符合 QC 标准的
2012年10月2日
首次发布 (估计)
2012年10月4日
研究记录更新
最后更新发布 (估计)
2012年10月4日
上次提交的符合 QC 标准的更新
2012年10月2日
最后验证
2012年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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