International Journal of Hematology

, Volume 89, Issue 3, pp 332–341

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

  • 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
Original Article

DOI: 10.1007/s12185-009-0260-2

Cite this article as:
Sakamaki, H., Ishizawa, K., Taniwaki, M. et al. Int J Hematol (2009) 89: 332. doi:10.1007/s12185-009-0260-2

Abstract

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.

Keywords

CMLPh+ ALLDasatinibImatinib resistantImatinib intolerant

Copyright information

© The Japanese Society of Hematology 2009

Authors and Affiliations

  • Hisashi Sakamaki
    • 1
  • Ken-ichi Ishizawa
    • 2
  • Masafumi Taniwaki
    • 3
  • Shin Fujisawa
    • 4
  • Yasuo Morishima
    • 5
  • Kensei Tobinai
    • 6
  • Masaya Okada
    • 7
  • Kiyoshi Ando
    • 8
  • Noriko Usui
    • 9
  • Shuichi Miyawaki
    • 10
  • Atae Utsunomiya
    • 11
  • Nobuhiko Uoshima
    • 12
  • Tadashi Nagai
    • 13
  • Tomoki Naoe
    • 14
  • Toshiko Motoji
    • 15
  • Itsuro Jinnai
    • 16
  • Mitsune Tanimoto
    • 17
  • Yasushi Miyazaki
    • 18
  • Kazunori Ohnishi
    • 19
  • Shinsuke Iida
    • 20
  • Shinichiro Okamoto
    • 21
  • Taku Seriu
    • 22
  • Ryuzo Ohno
    • 23
  1. 1.Department of HematologyMetropolitan Komagome HospitalTokyoJapan
  2. 2.Tohoku UniversitySendaiJapan
  3. 3.Kyoto Prefectural University of MedicineKyotoJapan
  4. 4.Yokohama City University Medical CenterYokohamaJapan
  5. 5.Aichi Cancer CenterNagoyaJapan
  6. 6.National Cancer CenterTokyoJapan
  7. 7.Hyogo Medical UniversityNishinomiyaJapan
  8. 8.Tokai UniversityIseharaJapan
  9. 9.Jikei University School of MedicineTokyoJapan
  10. 10.Saiseikai Maebashi HospitalMaebashiJapan
  11. 11.Jiaikai Imamura Hospital Branch HospitalKagoshimaJapan
  12. 12.Matsushita Memorial HospitalMoriguchiJapan
  13. 13.Jichi Medical SchoolShimotsukeJapan
  14. 14.Nagoya UniversityNagoyaJapan
  15. 15.Tokyo Women’s Medical UniversityTokyoJapan
  16. 16.Saitama Medical UniversityIrumaJapan
  17. 17.Okayama UniversityOkayamaJapan
  18. 18.Nagasaki UniversityNagasakiJapan
  19. 19.Hamamatsu University School of MedicineHamamatsuJapan
  20. 20.Nagoya City UniversityNagoyaJapan
  21. 21.Keio UniversityTokyoJapan
  22. 22.Bristol-Myers K.K.TokyoJapan
  23. 23.Aichi Shukutoku UniversityNagoyaJapan