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  • 1.
    Osterborg, Anders
    et al.
    Dept Haematol, Karolinska Univ Hosp, Stockholm, Sweden.
    Wierda, William G.
    M D Anderson Canc Ctr, Univ Texas, Houston TX, USA; Canc Therapy Res Ctr, San Antonio TX, USA.
    Mayer, Jiri
    Fac Hosp Brno, Dept Internal Med Haematooncol, University Hospital, Brno, Czech Republic.
    Hess, Georg
    Johannes Gutenberg Univ, Mainz, Germany.
    Hillmen, Peter
    Leeds Teaching Hosp, Leeds, England.
    Schetelig, Johannes
    Univ Klinickum Carl Gustav Carus, Dresden, Germany.
    Schuh, Anna
    Churchill Hosp, Oxford, England.
    Smolej, Lukas
    Fac Med Hradec Kralove, Univ Hosp, Hradec Kralove, Czech Republic; Charles Univ Prague, Hradec Kralove, Czech Republic.
    Beck, Christian
    Haematol Onkolog Inst, Moenchengladbach, Germany.
    Dreyfus, Brigitte
    Hop Jean Bernanrd, Poitiers, France.
    Hellman, Andrzej
    Akad Med Gdansku, Gdansk, Poland.
    Kozlowski, Piotr
    Örebro University Hospital.
    Pfreundschuh, Michael
    Univ Saarlandes Kliniken, Homburg, Germany.
    Rizzi, Rita
    Azienda ospedaliero-universitaria consorziale policlinico, Bari, Italy.
    Spacek, Martin
    Fak Nemocnice, Prague, Czech Republic..
    Phillips, Jennifer L.
    GlaxoSmithKline, Collegeville PA, USA.
    Gupta, Ira V.
    Williams, Vanessa
    Glaxo SmithKline, Durham NC, USA.
    Jewell, Roxanne C.
    Glaxo SmithKline, Durham NC ,USA..
    Nebot, Noelia
    Glaxo SmithKline, Durham NC, USA.
    Lisby, Steen
    Genmab AS, Copenhagen, Denmark.
    Dyer, Martin J. S.
    Ernest & Helen Scott Haematol Res Inst, Univ Leicester, Leicester, England.
    Ofatumumab retreatment and maintenance in fludarabine-refractory chronic lymphocytic leukaemia patients2015In: British Journal of Haematology, ISSN 0007-1048, E-ISSN 1365-2141, Vol. 170, no 1, p. 40-49Article in journal (Refereed)
    Abstract [en]

    There are limited data on retreatment with monoclonal antibodies (mAb) in patients with chronic lymphocytic leukaemia (CLL). In a pivotal study, ofatumumab (human anti-CD20 mAb) monotherapy demonstrated a 47% objective response rate (ORR) in fludarabine refractory CLL patients. From this study, a subset of 29 patients who had at least stable disease and then progressed were retreated with eight weekly ofatumumab infusions (induction treatment period), followed by monthly infusions for up to 2years (maintenance treatment period). The ORR after 8weeks of induction retreatment was 45% and 24% had continued disease control after maintenance at 52weeks. Efficacy and safety of the retreated patients were compared with their initial results in the pivotal study. Response duration was 241months vs. 68months; time to next therapy was 148months vs. 123months; and progression-free survival was 74months vs. 79months (medians). Upon retreatment, 72% had infusion reactions, mostly Grade 1-2. Three patients had fatal infections. In summary, ofatumumab retreatment and maintenance therapy was feasible in patients with heavily pretreated CLL and appeared to result in more durable disease control than initial ofatumumab treatment in this subset of patients who may have a more favourable disease profile.

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