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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

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Authors:
  • Coiffier, Bertrand ;
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    unknown
  • Losic, Nedjad ;
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    unknown
  • Rønn, Birgitte Biilmann ;
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    unknown
  • Lepretre, Stéphane ;
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    unknown
  • Pedersen, Lars Møller ;
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    unknown
  • Gadeberg, Ole ;
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    unknown
  • Frederiksen, Henrik ;
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    Orcid logo0000-0001-8905-0220
    Haematology, Department of Clinical Research, Faculty of Health Sciences, SDU
  • van Oers, Marinus H J ;
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    unknown
  • Wooldridge, James ;
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    unknown
  • Kloczko, Janusz ;
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    unknown
  • Holowiecki, Jerzy ;
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    unknown
  • Hellmann, Andrzej ;
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    unknown
  • Walewski, Jan ;
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    unknown
  • Robak, Tadeusz ;
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  • Petersen, Jørgen
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DOI:
10.1111/j.1365-2141.2010.08193.x
Abstract:
The 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.
Type:
Journal article
Language:
English
Published in:
British Journal of Haematology, 2010, Vol 150, Issue 1, p. 58-71
Keywords:
Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antigens, CD20; Antineoplastic Agents; Dose-Response Relationship, Drug; Female; Humans; Infusions, Intravenous; Leukemia, Lymphocytic, Chronic, B-Cell; Male; Middle Aged; Models, Biological; Recurrence; Survival Analysis; Treatment Outcome
Main Research Area:
Medical science
Publication Status:
Published
Review type:
Peer Review
Submission year:
2010
Scientific Level:
Scientific
ID:
16110324

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