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 IidaShinichiro Okamoto, Taku Seriu, Ryuzo Ohno

研究成果: Article査読

24 被引用数 (Scopus)

抄録

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.

本文言語English
ページ(範囲)332-341
ページ数10
ジャーナルInternational journal of hematology
89
3
DOI
出版ステータスPublished - 2009 4

ASJC Scopus subject areas

  • Hematology

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