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Blood, 1 February 2008, Vol. 111, No. 3, pp. 1094-1100.
Prepublished online as a Blood First Edition Paper on November 14, 2007; DOI 10.1182/blood-2007-09-111781.
 Previous Article | Next Article 
Submitted September 10, 2007
Accepted October 24, 2007
Safety and efficacy of ofatumumab, a fully human monoclonal anti-CD20 antibody, in patients with relapsed or refractory B-cell chronic lymphocytic leukemia. A phase I-II study
Bertrand Coiffier*, Stephane Lepretre, Lars Moller Pedersen, Ole Gadeberg, Henrik Fredriksen, Marinus H.J. van Oers, James Wooldridge, Janusz Kloczko, Jerzy Holowiecki, Andrzej Hellmann, Jan Walewski, Mimi Flensburg, Jorgen Petersen, and Tadeusz Robak
Departement d'Hematologie, Centre Hospitalier Lyon Sud, Pierre-Benite, France
Hematology, Centre Henri Becquerel, Rouen, France
Hematology, University Hospital Herlev, Herlev, Denmark
Hematology, Vejle Hospital, Vejle, Denmark
Hematology, Odense University Hospital, Odense, Denmark
Hematology, University of Amsterdam, Amsterdam, Netherlands
Hematology, The University of Iowa, Iowa City, IA, United States
Hematology, Klinika Hematologii, Bialystok, Poland
Hematology, Klinika Hematologii i Transplantacji Szpiku, Katowice, Poland
Klinika Hematologii, Akademii Medycznej, Gdansk, Poland
Hematology, Maria Sklodowska-Curie Memorial Institute and Cancer Centre, Warsaw, Poland
Genmab A/S, Copenhagen, Denmark
Hematology, Medical University of Lodz, Lodz, Poland
* Corresponding author; email: bertrand.coiffier{at}chu-lyon.fr.
Safety and efficacy of the fully human anti-CD20 monoclonal antibody, ofatumumab, was analyzed in an open label, multicenter, dose-escalating study including 33 patients with relapsed or refractory chronic lymphocytic leukemia. Three cohorts of 3 (A), 3 (B) and 27 (C) patients received 4, once weekly, infusions of ofatumumab at the following doses: A 1x100 mg + 3x500 mg; B 1x300 mg + 3x1000 mg; C 1x500 mg + 3x2000 mg. 67% of the patients were Binet stage B and median number of previous treatments was 3. The maximum tolerated dose was not reached. The majority of related adverse events occurred at first infusion and the number of adverse events decreased at each subsequent infusion. 17 of 33 patients (51%) experienced infections, 88% of them of grade 1-2. One event of interstitial pneumonia was fatal; all other cases resolved within one month. The response rate of cohort C was 50% (13/26), one patient having a nodular partial remission and 12 patients partial remission and 12 patients partial remission. In conclusion, ofatumumab was found to be well tolerated in patients with CLL in doses up to 2000 mg. Preliminary data on safety and objective response are encouraging and supports further studies on the role of ofatumumab in CLL patients. This trial was registered at www.clinicaltrials.gov as #NCT00093314.
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