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Expert Opinion on Drug Safety Volume 14, 2015 - Issue 12
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Drug Safety Evaluation

Ofatumumab for treating chronic lymphocytic leukemia: a safety profile

Anna Korycka-WołowiecDepartment of Hematology, Medical University of Lodz, Ciolkowskiego 2 Str, 93-510Lodz, Poland
,
Dariusz WołowiecDepartment of Hematology, Medical University of Wroclaw, Pasteura 4 Str, 50-367Wroclaw, Poland
&
Tadeusz RobakDepartment of Hematology, Medical University of Lodz, Ciolkowskiego 2 Str, 93-510Lodz, PolandCorrespondence[email protected]
Pages 1945-1959 | Published online: 13 Nov 2015

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•The results of phase I-II study indicated that ofatumumab is well tolerated in patients with relapsed or refractory chronic lymphocytic leukemia patients

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••The large phase II study showed that ofatumumab is an active and well-tolerated treatment for fludarabine-refractory chronic lymphocytic leukemia patients with very poor prognosis

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•The international phase II study indicated that a therapy with ofatumumab in combination with fludarabine and cyclophosphamide is active and safe in untreated chronic lymphocytic leukemia, including high-risk patients

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••The randomized, multicenter, open-label, phase III study (COMPLEMENT 1) showed that addition of ofatumumab to chlorambucil has an acceptable safety profile and is well tolerated in previously untreated chronic lymphocytic leukemia patients

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•A phase Ib/II study demonstrated that the combination of ofatumumab with ibrutinib exhibited clinical activity and an acceptable safety profile in heavily pretreated relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma patients

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