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Blood, 15 February 2008, Vol. 111, No. 4, pp. 1834-1839. Prepublished online as a Blood First Edition Paper on November 29, 2007December 10, 2007; DOI 10.1182/blood-2007-04-083196. This Article Full Text (PDF) Supplemental Appendix All Versions of this Article: blood-2007-04-083196v1 blood-2007-04-083196v2 111/4/1834    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by le Coutre, P. Articles by Kantarjian, H. Search for Related Content PubMed PubMed Citation Articles by le Coutre, P. Articles by Kantarjian, H. Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted April 2, 2007 Accepted November 18, 2007 Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is active in patients with imatinib-resistant or -intolerant accelerated phase chronic myelogenous leukemia Philipp le Coutre*, Oliver G Ottmann, Francis Giles, Dong-Wook Kim, Jorge Cortes, Norbert Gattermann, Jane F. Apperley, Richard A. Larson, Elisabetta Abruzzese, Stephen G. O'Brien, Kazimierz Kuliczkowski, Andreas Hochhaus, Francois-Xavier Mahon, Giuseppe Saglio, Marco Gobbi, Yok-Lam Kwong, Michele Baccarani, Timothy Hughes, Giovanni Martinelli, Jerald P. Radich, Ming Zheng, Yaping Shou, and Hagop Kantarjian Campus Virchow Klinikum, Charite Universitatsmedizine, Berlin, Germany Johann Wolfgang Goethe-Universitat, Frankfurt, Germany M.D. Anderson Cancer Center, Houston, TX, United States St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea, Republic of Heinrich-Heine-University, Duesseldorf, Germany Hammersmith Hospital, London, United Kingdom University of Chicago Cancer Center, Chicago, IL, United States Ospedale S. Eugenio, Tor Vergata University, Rome, Italy Royal Victoria Infirmary, Newcastle upon Tyne, United Kingdom Klinika Hematologii, Wroclaw, Poland Medizinische Fakultat Mannheim, Universitat Heidelberg, Mannheim, Germany Hopital Pellegrin, Bordeaux, France Ospedale S Luigi Gonzaga, Torino, Italy Ospedale S Martino, Genoa, Italy Queen Mary Hospital, Hong Kong, China Policlinico S Orsola Malpighi, Bologna, Italy Royal Adelaide Hospital, Adelaide, Australia Fred Hutchinson Cancer Research Center, Seattle, WA, United States Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States * Corresponding author; email: philipp.lecoutre{at}charite.de. Patients with imatinib-resistant or -intolerant accelerated phase CML (CML-AP) have very limited therapeutic options. Nilotinib is a highly selective BCR-ABL tyrosine kinase inhibitor. This phase II trial was designed to characterize the efficacy and safety of nilotinib (400 mg twice daily) in this patient population with hematologic response (HR) as primary efficacy endpoint. 119 patients were enrolled and had a median duration of treatment of 202 days (range 2-611). An HR was observed in 56 patients (47%, CI95% 38%-56%). Major cytogenetic response (MCyR) was observed in 35 patients (29%, CI95% 21%-39%). The median duration of HR has not been reached. Overall survival rate among the 119 patients after 12 months of follow-up was 79% (CI95% 70%-87%). Non-hematologic adverse events were mostly mild to moderate. Severe peripheral edema and pleural effusions were not observed. The most common Grade 3 hematologic adverse events were thrombocytopenia (35%) and neutropenia (21%). Grade 3 bilirubin and lipase elevations occurred in 9% and 18% of patients respectively, resulting in treatment discontinuation in one patient. In conclusion, nilotinib is an effective and well tolerated treatment in imatinib-resistant and -intolerant CML-AP. This trial is registered at www.clinicaltrials.gov as NCT00384228. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: G. Martinelli, I. Iacobucci, C. T. Storlazzi, M. Vignetti, F. Paoloni, D. Cilloni, S. Soverini, A. Vitale, S. Chiaretti, G. Cimino, et al. IKZF1 (Ikaros) Deletions in BCR-ABL1-Positive Acute Lymphoblastic Leukemia Are Associated With Short Disease-Free Survival and High Rate of Cumulative Incidence of Relapse: A GIMEMA AL WP Report J. Clin. Oncol., November 1, 2009; 27(31): 5202 - 5207. [Abstract] [Full Text] [PDF] T. Hughes, G. Saglio, S. Branford, S. Soverini, D.-W. Kim, M. C. Muller, G. Martinelli, J. Cortes, L. Beppu, E. Gottardi, et al. Impact of Baseline BCR-ABL Mutations on Response to Nilotinib in Patients With Chronic Myeloid Leukemia in Chronic Phase J. Clin. 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