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

Autor: Masafumi Taniwaki, Tomoki Naoe, Shuichi Miyawaki, Taku Seriu, Itsuro Jinnai, Tadashi Nagai, Kiyoshi Ando, Mitsune Tanimoto, Hisashi Sakamaki, K. Ishizawa, Atae Utsunomiya, Shinichiro Okamoto, Yasuo Morishima, Yasushi Miyazaki, R Ohno, Nobuhiko Uoshima, Noriko Usui, Kazunori Ohnishi, Shin Fujisawa, Masaya Okada, Toshiko Motoji, Shinsuke Iida, Kensei Tobinai
Rok vydání: 2009
Předmět:
Zdroj: International Journal of Hematology. 89:332-341
ISSN: 1865-3774
0925-5710
DOI: 10.1007/s12185-009-0260-2
Popis: 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. Dasatinibor= 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.
Databáze: OpenAIRE
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