Phase 1/2 clinical study of dasatinib in Japanese patients with chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia

被引：0
作者：
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
机构：
[1] Metropolitan Komagome Hospital,Department of Hematology
[2] Tohoku University,undefined
[3] Kyoto Prefectural University of Medicine,undefined
[4] Yokohama City University Medical Center,undefined
[5] Aichi Cancer Center,undefined
[6] National Cancer Center,undefined
[7] Hyogo Medical University,undefined
[8] Tokai University,undefined
[9] Jikei University School of Medicine,undefined
[10] Saiseikai Maebashi Hospital,undefined
[11] Jiaikai Imamura Hospital Branch Hospital,undefined
[12] Matsushita Memorial Hospital,undefined
[13] Jichi Medical School,undefined
[14] Nagoya University,undefined
[15] Tokyo Women’s Medical University,undefined
[16] Saitama Medical University,undefined
[17] Okayama University,undefined
[18] Nagasaki University,undefined
[19] Hamamatsu University School of Medicine,undefined
[20] Nagoya City University,undefined
[21] Keio University,undefined
[22] Bristol-Myers K.K.,undefined
[23] Aichi Shukutoku University,undefined
来源：
International Journal of Hematology | 2009年 / 89卷
关键词：
CML; Ph; ALL; Dasatinib; Imatinib resistant; Imatinib intolerant;
D O I：
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学科分类号：
摘要：
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 ≤ 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.
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页码：332 / 341
页数：9
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