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Blood, 15 June 2008, Vol. 111, No. 12, pp. 5486-5495. Prepublished online as a Blood First Edition Paper on April 4, 2008; DOI 10.1182/blood-2007-10-117671. This Article Full Text Full Text (PDF) All Versions of this Article: blood-2007-10-117671v1 111/12/5486    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 CrossRef Google Scholar Articles by Hagenbeek, A. Articles by Radford, J. PubMed PubMed Citation Articles by Hagenbeek, A. Articles by Radford, J. Related Collections Clinical Trials and Observations Related Articles in Blood Online Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL TRIALS AND OBSERVATIONS 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 Anton Hagenbeek1, Ole Gadeberg2, Peter Johnson3, Lars Møller Pedersen4, Jan Walewski5, Andrzej Hellmann6, Brian K. Link7, Tadeusz Robak8, Marek Wojtukiewicz9, Michael Pfreundschuh10, Michael Kneba11, Andreas Engert12, Pieter Sonneveld13, Mimi Flensburg14, Jørgen Petersen14, Nedjad Losic14, and John Radford15 1 University Medical Center Utrecht, Department of Hematology, Utrecht, The Netherlands; 2 Vejle Hospital, Vejle, Denmark; 3 Southampton General Hospital, Southampton, United Kingdom; 4 Herlev University Hospital, Herlev, Denmark; 5 Maria Sklodowska-Curie Memorial Institute & Cancer Centre, Warsaw, Poland; 6 Medical University of Gdansk, Department of Hematology, Gdansk, Poland; 7 University of Iowa, College of Medicine, Iowa City; 8 Medical University of Lodz, Department of Hematology, Lodz, Poland; 9 Comprehensive Cancer Center, Department of Medical Oncology, Bialystok, Poland; 10 Saarland University Medical School, Department of Internal Medicine I, Homburg, Germany; 11 University of Kiel, Department of Internal Medicine, Kiel, Germany; 12 University Hospital of Cologne, Cologne, Germany; 13 Erasmus Medical Center Rotterdam, Rotterdam, The Netherlands; 14 Genmab, Copenhagen, Denmark; and 15 Christie Hospital and University of Manchester, Manchester, United Kingdom Ofatumumab is a unique monoclonal antibody that targets a distinct small loop epitope on the CD20 molecule. Preclinical data show that ofatumumab is active against B-cell lymphoma/chronic lymphocytic leukemia cells with low CD20-antigen density and high expression of complement inhibitory molecules. In a phase 1/2 trial evaluating safety and efficacy of ofatumumab in relapsed or refractory follicular non-Hodgkin lymphoma (FL) grade 1 or 2, 4 dose groups of 10 patients received 4 weekly infusions of 300, 500, 700, or 1000 mg. Patients had a median of 2 prior FL therapies and 13% had elevated lactate dehydrogenase. No safety concerns or maximum tolerated dose was identified. A total of 274 adverse events were reported; 190 were judged related to ofatumumab, most occurring on the first infusion day with Common Terminology Criteria grade 1 or 2. Eight related events were grade 3. Treatment caused immediate and profound B-cell depletion, and 65% of patients reverted to negative BCL2 status. Clinical response rates ranged from 20% to 63%. Median time to progression for all patients/responders was 8.8/32.6 months, and median duration of response was 29.9 months at a median/maximum follow-up of 9.2/38.6 months. Ofatumumab is currently being evaluated in patients with rituximab-refractory FL. This trial was registered at www.clinicaltrials.gov as #NCT00092274 [ClinicalTrials.gov] . CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? Related Articles in Blood Online: Fully human monoclonal antibodies and targeted radionuclide therapy Tod W. Speer Blood 2008 112: 2584-2585. [Full Text] [PDF] Response: Multiple administrations of the fully human monoclonal antibody Ofatumumab Anton Hagenbeek Blood 2008 112: 2585. [Full Text] [PDF]

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