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Title: Expanding Nilotinib Access in Clinical Trials (ENACT), an open-label multicenter study of oral nilotinib in adult patients with imatinib-resistant or -intolerant chronic myeloid leukemia in accelerated phase or blast crisis
Authors: Franck E. Nicolini
Tamas Masszi
Zhixiang Shen
Neil J. Gallagher
Saengsuree Jootar
Bayard L. Powell
Pedro Enrique Dorlhiac-Llacer
Ming Zheng
Tomasz Szczudlo
Anna Turkina
Hopital Edouard Herriot
Szent Laszlo Hospital
Ruijin Hospital
Novartis International AG
Mahidol University
Wake Forest University
Universidade de Sao Paulo - USP
Novartis Pharmaceuticals Corporation
National Research Center for Hematology
Keywords: Biochemistry, Genetics and Molecular Biology;Medicine
Issue Date: 1-May-2012
Citation: Leukemia and Lymphoma. Vol.53, No.5 (2012), 907-914
Abstract: Nilotinib has shown favorable safety in patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic (CML-CP) or accelerated phase (CML-AP) who failed prior imatinib, and superior efficacy over imatinib in newly diagnosed Ph+ patients with CML-CP. Reported here are the efficacy and safety data for patients in CML-AP (n = 181) or blast crisis (CML-BC) (n = 190; myeloid BC, 133; lymphoid BC, 50; unknown, seven) enrolled in an expanded access phase IIIb study. Non-hematologic adverse events were mostly mild to moderate. Drug-related myelosuppression was generally manageable with dose reductions or interruptions and infrequently led to discontinuation of nilotinib. Drug-related grade 3/4 elevations in serum bilirubin and lipase were infrequent. While an analysis of efficacy was not the primary objective of this study, significant hematologic and cytogenetic responses were observed. These results support the safety and efficacy of nilotinib in patients with advanced CML in AP and BC. © 2012 Informa UK, Ltd.
ISSN: 10292403
Appears in Collections:Scopus 2011-2015

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