Original Article

International Journal of Hematology

, Volume 89, Issue 3, pp 332-341

First online:

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

  • Hisashi SakamakiAffiliated withDepartment of Hematology, Metropolitan Komagome Hospital Email author 
  • , Ken-ichi IshizawaAffiliated withTohoku University
  • , Masafumi TaniwakiAffiliated withKyoto Prefectural University of Medicine
  • , Shin FujisawaAffiliated withYokohama City University Medical Center
  • , Yasuo MorishimaAffiliated withAichi Cancer Center
  • , Kensei TobinaiAffiliated withNational Cancer Center
  • , Masaya OkadaAffiliated withHyogo Medical University
  • , Kiyoshi AndoAffiliated withTokai University
  • , Noriko UsuiAffiliated withJikei University School of Medicine
    • , Shuichi MiyawakiAffiliated withSaiseikai Maebashi Hospital
    • , Atae UtsunomiyaAffiliated withJiaikai Imamura Hospital Branch Hospital
    • , Nobuhiko UoshimaAffiliated withMatsushita Memorial Hospital
    • , Tadashi NagaiAffiliated withJichi Medical School
    • , Tomoki NaoeAffiliated withNagoya University
    • , Toshiko MotojiAffiliated withTokyo Women’s Medical University
    • , Itsuro JinnaiAffiliated withSaitama Medical University
    • , Mitsune TanimotoAffiliated withOkayama University
    • , Yasushi MiyazakiAffiliated withNagasaki University
    • , Kazunori OhnishiAffiliated withHamamatsu University School of Medicine
    • , Shinsuke IidaAffiliated withNagoya City University
    • , Shinichiro OkamotoAffiliated withKeio University
    • , Taku SeriuAffiliated withBristol-Myers K.K.
    • , Ryuzo OhnoAffiliated withAichi Shukutoku University

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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.


CML Ph+ ALL Dasatinib Imatinib resistant Imatinib intolerant