Document Detail


Phase 1/2 clinical study of dasatinib in Japanese patients with chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia.
MedLine Citation:
PMID:  19263190     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
A phase 1/2 study was conducted to assess the safety and efficacy of dasatinib in Japanese patients with chronic myelogenous leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph(+) ALL) resistant or intolerant to imatinib. In phase 1, 18 patients with chronic phase (CP) CML were treated with dasatinib 50, 70, or 90 mg twice daily to evaluate safety. Dasatinib <or= 90 mg twice daily was well tolerated. In phase 2, dasatinib 70 mg was given twice daily to CP-CML patients for 24 weeks and to CML patients in accelerated phase (AP)/blast crisis (BC) or Ph(+) ALL for 12 weeks. In the CP-CML group (n = 30) complete hematologic response was 90% and major cytogenetic response (MCyR) 53%. In the AP/BC-CML group (n = 11) major hematologic response (MaHR) was 64% and MCyR 27%, whereas in the Ph(+) ALL group (n = 13) MaHR was 38% and MCyR 54%. Dasatinib was well tolerated and most of the nonhematologic toxicities were mild or moderate. Dasatinib therapy resulted in high rates of hematologic and cytogenetic response, suggesting that dasatinib is promising as a new treatment for Japanese CML and Ph(+) ALL patients resistant or intolerant to imatinib.
Authors:
Hisashi Sakamaki; Ken-ichi Ishizawa; Masafumi Taniwaki; Shin Fujisawa; Yasuo Morishima; Kensei Tobinai; Masaya Okada; Kiyoshi Ando; Noriko Usui; Shuichi Miyawaki; Atae Utsunomiya; Nobuhiko Uoshima; Tadashi Nagai; Tomoki Naoe; Toshiko Motoji; Itsuro Jinnai; Mitsune Tanimoto; Yasushi Miyazaki; Kazunori Ohnishi; Shinsuke Iida; Shinichiro Okamoto; Taku Seriu; Ryuzo Ohno
Publication Detail:
Type:  Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article     Date:  2009-03-05
Journal Detail:
Title:  International journal of hematology     Volume:  89     ISSN:  1865-3774     ISO Abbreviation:  Int. J. Hematol.     Publication Date:  2009 Apr 
Date Detail:
Created Date:  2009-04-09     Completed Date:  2009-06-26     Revised Date:  2013-06-03    
Medline Journal Info:
Nlm Unique ID:  9111627     Medline TA:  Int J Hematol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  332-41     Citation Subset:  IM    
Affiliation:
Department of Hematology, Metropolitan Komagome Hospital, Tokyo, Japan. sakamaki@cick.jp
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Antineoplastic Agents / adverse effects,  pharmacology,  therapeutic use*
Asian Continental Ancestry Group
Fusion Proteins, bcr-abl / genetics,  metabolism
Humans
Leukemia, Myeloid, Chronic-Phase / drug therapy*,  genetics,  metabolism
Middle Aged
Mutation / genetics
Precursor Cell Lymphoblastic Leukemia-Lymphoma / drug therapy*,  genetics,  metabolism
Pyrimidines / adverse effects,  pharmacology,  therapeutic use*
Thiazoles / adverse effects,  pharmacology,  therapeutic use*
Chemical
Reg. No./Substance:
0/Antineoplastic Agents; 0/Fusion Proteins, bcr-abl; 0/Pyrimidines; 0/Thiazoles; RBZ1571X5H/dasatinib

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