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 & 3 others Shinichiro Okamoto, Taku Seriu, Ryuzo Ohno

Research output: Contribution to journalArticle

23 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)332-341
Number of pages10
JournalInternational Journal of Hematology
Volume89
Issue number3
DOIs
Publication statusPublished - Apr 2009

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Philadelphia Chromosome
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Chronic Phase
Cytogenetics
Blast Crisis
Safety
Dasatinib
Clinical Studies
Therapeutics

Keywords

  • CML
  • Dasatinib
  • Imatinib intolerant
  • Imatinib resistant
  • Ph ALL

ASJC Scopus subject areas

  • Hematology

Cite this

Phase 1/2 clinical study of dasatinib in Japanese patients with chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia. / Sakamaki, Hisashi; Ishizawa, Ken Ichi; Taniwaki, Masafumi; Fujisawa, Shin; Morishima, Yasuo; Tobinai, Kensei; Okada, Masaya; Ando, Kiyoshi; Usui, Noriko; Miyawaki, Shuichi; Utsunomiya, Atae; Uoshima, Nobuhiko; Nagai, Tadashi; Naoe, Tomoki; Motoji, Toshiko; Jinnai, Itsuro; Tanimoto, Mitsune; Miyazaki, Yasushi; Ohnishi, Kazunori; Iida, Shinsuke; Okamoto, Shinichiro; Seriu, Taku; Ohno, Ryuzo.

In: International Journal of Hematology, Vol. 89, No. 3, 04.2009, p. 332-341.

Research output: Contribution to journalArticle

Sakamaki, H, Ishizawa, KI, Taniwaki, M, Fujisawa, S, Morishima, Y, Tobinai, K, Okada, M, Ando, K, Usui, N, Miyawaki, S, Utsunomiya, A, Uoshima, N, Nagai, T, Naoe, T, Motoji, T, Jinnai, I, Tanimoto, M, Miyazaki, Y, Ohnishi, K, Iida, S, Okamoto, S, Seriu, T & Ohno, R 2009, 'Phase 1/2 clinical study of dasatinib in Japanese patients with chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia', International Journal of Hematology, vol. 89, no. 3, pp. 332-341. https://doi.org/10.1007/s12185-009-0260-2
Sakamaki, Hisashi ; Ishizawa, Ken Ichi ; Taniwaki, Masafumi ; Fujisawa, Shin ; Morishima, Yasuo ; Tobinai, Kensei ; Okada, Masaya ; Ando, Kiyoshi ; Usui, Noriko ; Miyawaki, Shuichi ; Utsunomiya, Atae ; Uoshima, Nobuhiko ; Nagai, Tadashi ; Naoe, Tomoki ; Motoji, Toshiko ; Jinnai, Itsuro ; Tanimoto, Mitsune ; Miyazaki, Yasushi ; Ohnishi, Kazunori ; Iida, Shinsuke ; Okamoto, Shinichiro ; Seriu, Taku ; Ohno, Ryuzo. / Phase 1/2 clinical study of dasatinib in Japanese patients with chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia. In: International Journal of Hematology. 2009 ; Vol. 89, No. 3. pp. 332-341.
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