A multicentre,phase II trial of ofatumumab monotherapy in relapsed/progressive diffuse large B‐cell lymphoma |
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| Authors: | Bertrand Coiffier John Radford André Bosly Giovanni Martinelli Gabriela Barca Andrew Davies Didier Decaudin Eve Gallop‐Evans Swaminathan Padmanabhan‐Iyer Koen Van Eygen Ka Lung Wu Ira V. Gupta Thomas S. Lin Nancy Goldstein Roxanne C. Jewell Paul Winter Steen Lisby study investigators |
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| Affiliation: | 1. Service d'Hematologie, Hospices Civils de Lyon, , Lyon, France;2. The Christie NHS Foundation Trust and The University of Manchester, , Manchester, UK;3. Service d'Hématologie, Clinique Universitaires UCL de Mont‐Godinne, , Yvoir, Belgium;4. Divisione di Ematoncologia, Istituto Europeo di Oncologia, , Milan, Italy;5. Department of Hematology, Coltea Clinical Hospital, , Bucharest, Romania;6. Cancer Research UK Centre, University of Southampton, , Southampton, UK;7. Departments of Medical Oncology and Translational Research, Institut Curie, , Paris, France;8. Department of Clinical Oncology, Velindre Cancer Centre, , Cardiff, UK;9. Institute for Drug Development, University of Texas Health Science Center at San Antonio, , San Antonio, TX, USA;10. Oncologisch Centrum, AZ Groeninge, , Kortrijk, Belgium;11. Department of Hematology, Ziekenhuis Stuivenberg, , Antwerpen, Belgium;12. GlaxoSmithKline, , Collegeville, PA, USA;13. GlaxoSmithKline, , Research Triangle Park, NC, USA;14. GlaxoSmithKline, , London, UK;15. Genmab, , Copenhagen, Denmark |
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| Abstract: | ![]()
This international, multicentre phase II study was conducted to assess ofatumumab, a human anti‐CD20 monoclonal antibody, in patients with relapsed/progressive diffuse large B‐cell lymphoma (DLBCL) who were ineligible for autologous stem cell transplantation (TI) or who had relapse/progression after transplantation (PT). Eighty‐one patients received ofatumumab 300 mg intravenously (IV) on Day 1, followed by seven weekly IV infusions of 1000 mg. Patients in the TI and PT groups had received a median of 3 (range, 1–7) and 5 (range, 2–7) prior therapies, respectively. One‐third of patients did not respond to the last prior therapy, and 53% had failed two or more rituximab‐containing therapies. Overall response rate was 13% for the TI group (seven partial responses) and 8% for the PT group (two complete responses). Median progression‐free survival was 2·6 months, and median duration of response was 9·5 months. The most common Grade 3–4 adverse events were neutropenia (11%), leucopenia (6%), lymphopenia (6%) and thrombocytopenia (6%). Sixteen deaths have been reported, with disease progression as the most common cause of death. In conclusion, ofatumumab monotherapy was well tolerated and provided clinical benefit to some DLBCL patients in this study. This trial was registered at www.clinicaltrials.gov (NCT00622388). |
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| Keywords: | haematological malignancies immunotherapy lymphoid malignancies non‐Hodgkin lymphoma diffuse large B‐cell lymphoma |
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