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慢性淋巴细胞白血病新初始治疗方案研究

2011-07-03 MedSci原创 MedSci原创

白血病
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John C. Byrd,医学博士 研究题目：来那度胺（Revlimid ®） 和利妥昔单抗用于慢性淋巴细胞白血病(CLL)一线治疗的多中心试验 协作者：CLL研究协会协调国家癌症研究所和Celgene对本研究的支持 ClinicalTrials.gov网站标识：NCT00628238 参与的研究中心：本研究是CLL研究协会下的一项临床性国家多中心研究。 临床人数：70名患者

John C. Byrd,医学博士
研究题目：来那度胺（Revlimid ®） 和利妥昔单抗用于慢性淋巴细胞白血病(CLL)一线治疗的多中心试验
协作者：CLL研究协会协调国家癌症研究所和Celgene对本研究的支持
ClinicalTrials.gov网站标识：NCT00628238
参与的研究中心：本研究是CLL研究协会下的一项临床性国家多中心研究。
临床人数：70名患者

研究设计
这是一项II期研究，有症状但先前未经治疗的CLL患者依年龄分为两组：＜65岁组和≥65岁组。在治疗的第一个月期间，使用来那度胺(Revlimid®)作为一种单一药剂，采用剂量按比例增加的方案，有计划地减少肿瘤复发的风险。第2个周期开始利妥昔单抗联合来那度胺持续治疗，时间最长为7个周期。治疗方案中包括详细的相关性研究结果，以评估来那度胺在第1周期治疗中对肿瘤细胞和免疫效应细胞的独立效应、药代动力学特征和最小残留疾病情况。

原理
来那度胺已经显示对先前未经治疗但有症状的CLL具有临床活性。已报告的作用机理包括免疫调节、干扰微环境信号、抑制血管生成；在一些类型的肿瘤中，还包括直接诱导细胞凋亡。来那度胺也可使抗体介导的细胞毒性（ADCC）增强。基于这一特性，研究设计者联合应用来那度胺和利妥昔单抗-抗-CD20嵌合抗体，此疗法不仅可以提供ADCC过程所需的抗体成分，还对先前未经治疗的CLL具有独立的治疗作用。

评论
设计本研究的目的在于通过联合两种独立的、可能具有协同作用的活性生物学疗法来展现一种新的、非以化疗为基础的CLL疗法。鉴于这些治疗CLL的新疗法具有高活性和强针对性(如CAL-101, PCI32765)，对这些药物联合利妥昔单抗有效性进行的研究（比如本研究），有望将CLL的治疗方法改变为一种不会产生细胞毒和骨髓抑制的化学疗法。

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    2011-08-21 zhangjiqing

    #治疗方案#

    0

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    2012-01-27 sunyl07

    #淋巴细胞白血病#

    0

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    2011-07-17 hb2008ye

    #初始治疗#

    0

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    2011-07-05 wetgdt

    #淋巴细胞#

    0

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