Once-weekly ofatumumab in untreated or relapsed Waldenström's macroglobulinaemia: an open-label, single-arm, phase 2 study

Ghobrial, 2003, Waldenström macroglobulinaemia, Lancet Oncol, 4, 679, 10.1016/S1470-2045(03)01246-4 Owen, 2003, Developing diagnostic criteria in Waldenstrom's macroglobulinemia, Semin Oncol, 30, 196, 10.1053/sonc.2003.50069 Pangalis, 2005, Differential diagnosis of Waldenström's macroglobulinemia and other B-cell disorders, Clin Lymphoma, 5, 235, 10.3816/CLM.2005.n.006 Leleu, 2009, Increased incidence of transformation and myelodysplasia/acute leukemia in patients with Waldenström macroglobulinemia treated with nucleoside analogs, J Clin Oncol, 27, 250, 10.1200/JCO.2007.15.1530 Leleu, 2009, Balancing risk versus benefit in the treatment of Waldenström's macroglobulinemia patients with nucleoside analogue-based therapy, Clin Lymphoma Myeloma, 9, 71, 10.3816/CLM.2009.n.018 Treon, 2009, How I treat Waldenstrom macroglobulinemia, Blood, 114, 2375, 10.1182/blood-2009-05-174359 Treon, 2008, Thalidomide and rituximab in Waldenstrom macroglobulinemia, Blood, 112, 4452, 10.1182/blood-2008-04-150854 Gertz, 2012, Waldenström macroglobulinemia: 2012 update on diagnosis, risk stratification, and management, Am J Hematol, 87, 503, 10.1002/ajh.23192 Byrd, 1999, Rituximab therapy in Waldenstrom's macroglobulinemia: preliminary evidence of clinical activity, Ann Oncol, 10, 1525, 10.1023/A:1008350208019 Dimopoulos, 2002, Treatment of Waldenström's macroglobulinemia with rituximab, J Clin Oncol, 20, 2327, 10.1200/JCO.2002.09.039 Dimopoulos, 2004, Treatment of Waldenstrom's macroglobulinemia with rituximab: prognostic factors for response and progression, Leuk Lymphoma, 45, 2057, 10.1080/10428190410001723287 Foran, 2000, European phase II study of rituximab (chimeric anti-CD20 monoclonal antibody) for patients with newly diagnosed mantle-cell lymphoma and previously treated mantle-cell lymphoma, immunocytoma, and small B-cell lymphocytic lymphoma, J Clin Oncol, 18, 317, 10.1200/JCO.2000.18.2.317 Gertz, 2004, Multicenter phase 2 trial of rituximab for Waldenström macroglobulinemia (WM): an Eastern Cooperative Oncology Group Study (E3A98), Leuk Lymphoma, 45, 2047, 10.1080/10428190410001714043 Ghobrial, 2004, Initial immunoglobulin M ‘flare’ after rituximab therapy in patients diagnosed with Waldenström macroglobulinemia: an Eastern Cooperative Oncology Group Study, Cancer, 101, 2593, 10.1002/cncr.20658 Treon, 2004, Paradoxical increases in serum IgM and viscosity levels following rituximab in Waldenström's macroglobulinemia, Ann Oncol, 15, 1481, 10.1093/annonc/mdh403 Teeling, 2006, The biological activity of human CD20 monoclonal antibodies is linked to unique epitopes on CD20, J Immunol, 177, 362, 10.4049/jimmunol.177.1.362 Pawluczkowycz, 2009, 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, 183, 749, 10.4049/jimmunol.0900632 Teeling, 2004, Characterization of new human CD20 monoclonal antibodies with potent cytolytic activity against non-Hodgkin lymphomas, Blood, 104, 1793, 10.1182/blood-2004-01-0039 Wierda, 2010, Ofatumumab as single-agent CD20 immunotherapy in fludarabine-refractory chronic lymphocytic leukemia, J Clin Oncol, 28, 1749, 10.1200/JCO.2009.25.3187 Österborg, 2015, Ofatumumab monotherapy in fludarabine-refractory chronic lymphocytic leukemia: final results from a pivotal study, Haematologica, 100, e311 Hillmen, 2015, Chlorambucil plus ofatumumab versus chlorambucil alone in previously untreated patients with chronic lymphocytic leukaemia (COMPLEMENT 1): a randomised, multicentre, open-label phase 3 trial, Lancet, 385, 1873, 10.1016/S0140-6736(15)60027-7 Czuczman, 2015, Results of a phase II study of bendamustine and ofatumumab in untreated indolent B cell non-Hodgkin's lymphoma, Ann Hematol, 94, 633, 10.1007/s00277-014-2269-8 Gertz, 2012, Waldenström macroglobulinemia, Hematology, 17, S112, 10.1179/102453312X13336169156212 Gertz, 2003, Treatment recommendations in Waldenström's macroglobulinemia: consensus panel recommendations from the Second International Workshop on Waldenström's macroglobulinemia, Semin Oncol, 30, 121, 10.1053/sonc.2003.50039 Kimby, 2006, Update on recommendations for assessing response from the Third International Workshop on Waldenström's macroglobulinemia, Clin Lymphoma Myeloma, 6, 380, 10.3816/CLM.2006.n.013 Weber, 2003, Uniform response criteria in Waldenström's macroglobulinemia: consensus panel recommendations from the Second International Workshop on Waldenström's macroglobulinemia, Semin Oncol, 30, 127, 10.1053/sonc.2003.50037 Struemper, 2014, Population pharmacokinetics of ofatumumab in patients with chronic lymphocytic leukemia, follicular lymphoma, and rheumatoid arthritis, J Clin Pharmacol, 54, 818, 10.1002/jcph.268 Morel, 2009, International prognostic scoring system for Waldenström's macroglobulinemia, Blood, 113, 4163, 10.1182/blood-2008-08-174961