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https://hdl.handle.net/2440/58996
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Type: | Journal article |
Title: | A Phase I/II study of nilotinib in Japanese patients with imatinib-resistant or -intolerant Ph plus CML or relapsed/refractory Ph plus ALL |
Author: | Tojo, A. Usuki, K. Urabe, A. Maeda, Y. Kobayashi, Y. Jinnai, I. Ohyashiki, K. Nishimura, M. Kawaguchi, T. Tanaka, H. Miyamura, K. Miyazaki, Y. Hughes, T. Branford, S. Okamoto, S. Ishikawa, J. Okada, M. Usui, N. Tanii, H. Amagasaki, T. et al. |
Citation: | International Journal of Hematology, 2009; 89(5):679-688 |
Publisher: | Garden Jennings Publ Co Ltd |
Issue Date: | 2009 |
ISSN: | 0925-5710 1865-3774 |
Statement of Responsibility: | Arinobu Tojo... Timothy Hughes... Susan Branford... et al. |
Abstract: | Nilotinib is a second-generation BCR-ABL kinase inhibitor with improved potency and selectivity compared to imatinib. A Phase I/II dose-escalation study was designed to evaluate the efficacy, safety, and pharmacokinetics of nilotinib in Japanese patients with imatinibresistant or -intolerant Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) or relapsed/ refractory Ph+ acute lymphoblastic leukemia (ALL). A total of 34 patients were evaluated in this analysis and had a median duration of drug exposure of 293 (range 13–615) days. All 6 CML-CP patients without complete hematologic response (CHR) at baseline rapidly achieved CHR. A major cytogenetic response was achieved in 94% of patients with CML-CP, including a complete cytogenetic response in 69%. A major molecular response was achieved by 56%. These responses were also observed in patients with CML in advanced stages and Ph+ ALL. Non-hematologic adverse events were mostly mild to moderate. Grade 3 or 4 neutropenia and thrombocytopenia occurred in 50 and 28% of patients, respectively. Overall, the results of this study suggest that nilotinib induced significant responses inimatinib-resistant or -intolerant patients with CML-CP and CML in advanced stages and Ph+ ALL. The results of this study confirmed the efficacy and safety of nilotinib in Japanese patients. |
Keywords: | Nilotinib CML BCR-ABL Imatinib resistant Ph+ ALL |
Rights: | Copyright The Japanese Society of Hematology 2009 |
DOI: | 10.1007/s12185-009-0327-0 |
Published version: | http://dx.doi.org/10.1007/s12185-009-0327-0 |
Appears in Collections: | Aurora harvest Medicine publications |
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