International Journal of Hematology

DOI: 10.1007/s12185-009-0260-2 Pages: 332-341

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

1. Metropolitan Komagome Hospital, Department of Hematology

2. Tohoku University

3. Kyoto Prefectural University of Medicine

4. Yokohama City University Medical Center

5. Aichi Cancer Center

6. National Cancer Center

7. Hyogo Medical University

8. Tokai University

9. Jikei University School of Medicine

10. Saiseikai Maebashi Hospital

11. Jiaikai Imamura Hospital Branch Hospital

12. Matsushita Memorial Hospital

13. Jichi Medical School

14. Nagoya University

15. Tokyo Women’s Medical University

16. Saitama Medical University

17. Okayama University

18. Nagasaki University

19. Hamamatsu University School of Medicine

20. Nagoya City University

21. Keio University

22. Bristol-Myers K.K.

23. Aichi Shukutoku University

Correspondence to:
Hisashi Sakamaki
Tel: +81-3-38232101
Fax: +81-3-338235433



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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