Please use this identifier to cite or link to this item:
https://hdl.handle.net/2440/58996
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dc.contributor.author | Tojo, A. | - |
dc.contributor.author | Usuki, K. | - |
dc.contributor.author | Urabe, A. | - |
dc.contributor.author | Maeda, Y. | - |
dc.contributor.author | Kobayashi, Y. | - |
dc.contributor.author | Jinnai, I. | - |
dc.contributor.author | Ohyashiki, K. | - |
dc.contributor.author | Nishimura, M. | - |
dc.contributor.author | Kawaguchi, T. | - |
dc.contributor.author | Tanaka, H. | - |
dc.contributor.author | Miyamura, K. | - |
dc.contributor.author | Miyazaki, Y. | - |
dc.contributor.author | Hughes, T. | - |
dc.contributor.author | Branford, S. | - |
dc.contributor.author | Okamoto, S. | - |
dc.contributor.author | Ishikawa, J. | - |
dc.contributor.author | Okada, M. | - |
dc.contributor.author | Usui, N. | - |
dc.contributor.author | Tanii, H. | - |
dc.contributor.author | Amagasaki, T. | - |
dc.contributor.author | et al. | - |
dc.date.issued | 2009 | - |
dc.identifier.citation | International Journal of Hematology, 2009; 89(5):679-688 | - |
dc.identifier.issn | 0925-5710 | - |
dc.identifier.issn | 1865-3774 | - |
dc.identifier.uri | http://hdl.handle.net/2440/58996 | - |
dc.description.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. | - |
dc.description.statementofresponsibility | Arinobu Tojo... Timothy Hughes... Susan Branford... et al. | - |
dc.language.iso | en | - |
dc.publisher | Garden Jennings Publ Co Ltd | - |
dc.rights | Copyright The Japanese Society of Hematology 2009 | - |
dc.source.uri | http://dx.doi.org/10.1007/s12185-009-0327-0 | - |
dc.subject | Nilotinib | - |
dc.subject | CML | - |
dc.subject | BCR-ABL | - |
dc.subject | Imatinib resistant | - |
dc.subject | Ph+ ALL | - |
dc.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 | - |
dc.type | Journal article | - |
dc.identifier.doi | 10.1007/s12185-009-0327-0 | - |
pubs.publication-status | Published | - |
dc.identifier.orcid | Hughes, T. [0000-0002-0910-3730] [0000-0002-7990-4509] | - |
dc.identifier.orcid | Branford, S. [0000-0002-1964-3626] [0000-0002-5095-7981] | - |
Appears in Collections: | Aurora harvest Medicine publications |
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