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

作者：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

来源：International Journal of Hematology, 2009, 89(3): 332-341.

DOI：10.1007/s12185-009-0260-2

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

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 a parts per thousand currency sign 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.

• 出版日期2009-4