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A Phase I/II study of nilotinib in Japanese patients with imatinib-resistant or -intolerant Ph+ CML or relapsed/refractory Ph+ ALL.

Author(s): 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, Natori H, Naoe T

Affiliation(s): The Institute of Medical Science, The University of Tokyo, Tokyo, Japan. a-tojo@ims.u-tokyo.ac.jp

Publication date & source: 2009-06, Int J Hematol., 89(5):679-88. Epub 2009 May 19.

Publication type: Clinical Trial, Phase I; Clinical Trial, Phase II

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 imatinib-resistant 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 in imatinib-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.

Page last updated: 2009-10-20

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