Study design
DISEASE PROGRESSION
The present study was designed as multi-institutional, open-label, investigator-initiated phase Ia and Ib clinical trials on KW-0761 (mogamulizumab). The investigational drug KW-0761 was provided by Kyowa Kirin. Patients received 8 intravenous infusions of KW-0761 weekly followed by monthly infusions until disease progression or patient refusal. The phase Ia study consisted of a non-randomized 3+3 dose-escalation design with 0.1, 0.5, and 1.0 mg/kg of KW-0761, and the sample size was set using Fibonacci’s method (