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    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.

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    Authors
    Hagenbeek, Anton
    Gadeberg, Ole
    Johnson, Peter W
    Pedersen, Lars Møller
    Walewski, Jan
    Hellmann, Andrzej
    Link, Brian K
    Robak, Tadeusz
    Wojtukiewicz, Marek
    Pfreundschuh, Michael
    Kneba, Michael
    Engert, Andreas
    Sonneveld, Pieter
    Flensburg, Mimi
    Petersen, Jørgen
    Losic, Nedjad
    Radford, John A
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    Affiliation
    University Medical Center Utrecht, Department of Hematology, Utrecht, The Netherlands. a.hagenbeek@umcutrecht.nl
    Issue Date
    2008-06-15
    
    Metadata
    Show full item record
    Abstract
    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.
    Citation
    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. 2008, 111 (12):5486-95 Blood
    Journal
    Blood
    URI
    http://hdl.handle.net/10541/59053
    DOI
    10.1182/blood-2007-10-117671
    PubMed ID
    18390837
    Type
    Article
    Language
    en
    ISSN
    1528-0020
    ae974a485f413a2113503eed53cd6c53
    10.1182/blood-2007-10-117671
    Scopus Count
    Collections
    All Christie Publications
    Medical Oncology

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