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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. This Article Full Text Full Text (PDF) All Versions of this Article: blood-2007-09-111781v1 111/3/1094    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Coiffier, B. Articles by Robak, T. Search for Related Content PubMed PubMed Citation Articles by Coiffier, B. Articles by Robak, T. Related Collections Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL TRIALS AND OBSERVATIONS 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 1-2 study Bertrand Coiffier1, Stéphane Lepretre2, Lars Møller Pedersen3, Ole Gadeberg4, Henrik Fredriksen5, Marinus H. J. van Oers6, James Wooldridge7, Janusz Kloczko8, Jerzy Holowiecki9, Andrzej Hellmann10, Jan Walewski11, Mimi Flensburg12, Jørgen Petersen12, and Tadeusz Robak13 1 Département d'Hématologie, Centre Hospitalier Lyon Sud, Pierre-Benite Cedex, France; 2 Centre Henri Becquerel, Rouen, France; 3 University Hospital Herlev, Herlev, Denmark; 4 Vejle Hospital, Vejle, Denmark; 5 Odense University Hospital, Odense, Denmark; 6 University of Amsterdam, Amsterdam, the Netherlands; 7 University of Iowa, Iowa City; 8 Klinika Hematologii, Bialystok, Poland; 9 Klinika Hematologii i Transplantacji Szpiku, Katowice, Poland; 10 Klinika Hematologii Akademii Medycznej, Gdansk, Poland; 11 Maria Sklodowska-Curie Memorial Institute and Cancer Centre, Warsaw, Poland; 12 Genmab, Copenhagen, Denmark; 13 Medical University of Lodz, Lodz, Poland Safety and efficacy of the fully human anti-CD20 monoclonal antibody, ofatumumab, was analyzed in a 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) one 100 mg and three 500 mg; (B) one 300 mg and three 1000 mg; (C) one 500 mg and three 2000 mg. Sixty-seven percent of the patients were Binet stage B, and the 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. Seventeen (51%) of 33 patients 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. In conclusion, ofatumumab was found to be well tolerated in patients with chronic lymphocytic leukemia (CLL) in doses up to 2000 mg. Preliminary data on safety and objective response are encouraging and support further studies on the role of ofatumumab in CLL patients. This trial was registered at www.clinicaltrials.gov as no. NCT00093314 [ClinicalTrials.gov] . CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: F. Morschhauser, J. P. Leonard, L. Fayad, B. Coiffier, M.-O. Petillon, M. Coleman, S. J. Schuster, M. J.S. Dyer, H. Horne, N. Teoh, et al. Humanized Anti-CD20 Antibody, Veltuzumab, in Refractory/Recurrent Non-Hodgkin's Lymphoma: Phase I/II Results J. Clin. Oncol., July 10, 2009; 27(20): 3346 - 3353. [Abstract] [Full Text] [PDF] A. W. Pawluczkowycz, F. J. Beurskens, P. V. Beum, M. A. Lindorfer, J. G. J. van de Winkel, P. W. H. I. Parren, and R. P. Taylor Binding of Submaximal C1q Promotes Complement-Dependent Cytotoxicity (CDC) of B Cells Opsonized with Anti-CD20 mAbs Ofatumumab (OFA) or Rituximab (RTX): Considerably Higher Levels of CDC Are Induced by OFA than by RTX J. Immunol., July 1, 2009; 183(1): 749 - 758. [Abstract] [Full Text] [PDF] N. A. Johnson, M. Boyle, A. Bashashati, S. Leach, A. Brooks-Wilson, L. H. Sehn, M. Chhanabhai, R. R. Brinkman, J. M. Connors, A. P. Weng, et al. Diffuse large B-cell lymphoma: reduced CD20 expression is associated with an inferior survival Blood, April 16, 2009; 113(16): 3773 - 3780. [Abstract] [Full Text] [PDF] D. M. Goldenberg, E. A. Rossi, R. Stein, T. M. Cardillo, M. S. Czuczman, F. J. Hernandez-Ilizaliturri, H. J. Hansen, and C.-H. Chang Properties and structure-function relationships of veltuzumab (hA20), a humanized anti-CD20 monoclonal antibody Blood, January 29, 2009; 113(5): 1062 - 1070. [Abstract] [Full Text] [PDF] B. D. Cheson and J. P. Leonard Monoclonal Antibody Therapy for B-Cell Non-Hodgkin's Lymphoma N. Engl. J. Med., August 7, 2008; 359(6): 613 - 626. [Full Text] [PDF] A. Hagenbeek, O. Gadeberg, P. Johnson, L. Moller Pedersen, J. Walewski, A. Hellmann, B. K. Link, T. Robak, M. Wojtukiewicz, M. Pfreundschuh, et al. First clinical use of ofatumumab, a novel fully human anti-CD20 monoclonal antibody in relapsed or refractory follicular lymphoma: results of a phase 1/2 trial Blood, June 15, 2008; 111(12): 5486 - 5495. [Abstract] [Full Text] [PDF] S. O'Brien New Agents in the Treatment of CLL Hematology, January 1, 2008; 2008(1): 457 - 464. [Abstract] [Full Text] [PDF]

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