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首页> 外文期刊>British Journal of Haematology >Pharmacokinetics and pharmacokinetic/pharmacodynamic associations of ofatumumab, a human monoclonal CD20 antibody, in patients with relapsed or refractory chronic lymphocytic leukaemia: a phase 1–2 study
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Pharmacokinetics and pharmacokinetic/pharmacodynamic associations of ofatumumab, a human monoclonal CD20 antibody, in patients with relapsed or refractory chronic lymphocytic leukaemia: a phase 1–2 study

机译:ofatumumab,一种人类单克隆CD20抗体,在复发或难治性慢性淋巴细胞性白血病患者中的药代动力学和药代动力学/药效学关联:一项1至2期研究

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SummaryThe purpose of this phase 1–2 study was to investigate the association between the pharmacokinetic properties of ofatumumab, a human monoclonal CD20 antibody, and outcomes in 33 patients with relapsed/refractory chronic lymphocytic leukaemia receiving 4 weekly infusions of ofatumumab. The ofatumumab concentration profiles were fitted well by a two-compartment model with different elimination rate constant at first infusion compared to the remaining infusions in line with the observed rapid and sustained B-cell depletion. Exposure to ofatumumab was linked to clinical outcomes: high exposure was associated with higher probability of overall clinical response and longer progression-free survival. This association still remained statistically significant even when adjusting for relevant baseline covariates including tumour burden. The trial was registered at http://www.clinicaltrials.gov (NCT00093314).
机译:总结1-2期研究的目的是研究ofatumumab(人单克隆CD20抗体)的药代动力学特性与33例接受每周4次ofatumumab灌注治疗的复发/难治性慢性淋巴细胞白血病患者的预后之间的关系。奥法木单抗的浓度曲线通过两室模型很好地拟合,在第一次输注时,与其余输注相比,消除速率常数不同,这与观察到的快速持续B细胞耗竭相符。 ofatumumab的暴露与临床结果相关:高暴露与总体临床反应的可能性更高和更长的无进展生存期相关。即使在校正包括肿瘤负荷在内的相关基线协变量时,这种关联仍然保持统计学上的显着性。该试验已在http://www.clinicaltrials.gov(NCT00093314)上注册。

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