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

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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.

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Conflicts of interest statement

The authors indicated no potential conflicts of interest. T. S. is employee of Bristol-Myers K.K.

Author information

Authors and Affiliations

  1. Department of Hematology, Metropolitan Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo, 113-8677, Japan

    Hisashi Sakamaki

  2. Tohoku University, Sendai, Japan

    Ken-ichi Ishizawa

  3. Kyoto Prefectural University of Medicine, Kyoto, Japan

    Masafumi Taniwaki

  4. Yokohama City University Medical Center, Yokohama, Japan

    Shin Fujisawa

  5. Aichi Cancer Center, Nagoya, Japan

    Yasuo Morishima

  6. National Cancer Center, Tokyo, Japan

    Kensei Tobinai

  7. Hyogo Medical University, Nishinomiya, Japan

    Masaya Okada

  8. Tokai University, Isehara, Japan

    Kiyoshi Ando

  9. Jikei University School of Medicine, Tokyo, Japan

    Noriko Usui

  10. Saiseikai Maebashi Hospital, Maebashi, Japan

    Shuichi Miyawaki

  11. Jiaikai Imamura Hospital Branch Hospital, Kagoshima, Japan

    Atae Utsunomiya

  12. Matsushita Memorial Hospital, Moriguchi, Japan

    Nobuhiko Uoshima

  13. Jichi Medical School, Shimotsuke, Japan

    Tadashi Nagai

  14. Nagoya University, Nagoya, Japan

    Tomoki Naoe

  15. Tokyo Women’s Medical University, Tokyo, Japan

    Toshiko Motoji

  16. Saitama Medical University, Iruma, Japan

    Itsuro Jinnai

  17. Okayama University, Okayama, Japan

    Mitsune Tanimoto

  18. Nagasaki University, Nagasaki, Japan

    Yasushi Miyazaki

  19. Hamamatsu University School of Medicine, Hamamatsu, Japan

    Kazunori Ohnishi

  20. Nagoya City University, Nagoya, Japan

    Shinsuke Iida

  21. Keio University, Tokyo, Japan

    Shinichiro Okamoto

  22. Bristol-Myers K.K., Tokyo, Japan

    Taku Seriu

  23. Aichi Shukutoku University, Nagoya, Japan

    Ryuzo Ohno

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  1. Hisashi Sakamaki
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Correspondence to Hisashi Sakamaki.

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Sakamaki, H., Ishizawa, Ki., Taniwaki, M. et al. Phase 1/2 clinical study of dasatinib in Japanese patients with chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia. Int J Hematol 89, 332–341 (2009). https://doi.org/10.1007/s12185-009-0260-2

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  • DOI: https://doi.org/10.1007/s12185-009-0260-2

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