The purpose of this study is to evaluate the efficacy of KW-0761 intravenously administered eight times at one-week intervals in patients with CCR4-positive peripheral T/NK-cell lymphoma. The primary objective is to assess the antitumor effect in terms of best overall response, while the secondary objectives are to assess the antitumor effect in terms of best response by disease lesion, to assess the progression-free survival and to assess the overall survival. The safety and pharmacokinetic profiles of KW-0761 will be also evaluated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Enrollment
38
Intravenously 8 times at 1-week intervals
Kyushu University Hospital
Fukuoka, Japan
National Kyushu Cancer Center
Fukuoka, Japan
Tokai University Hospital
Isehara, Japan
Antitumor effect (best overall response)
Antitumor effect (best response by disease lesion), progression-free survival and overall survival
Adverse events and anti-KW-0761 antibody levels
Plasma KW-0761 concentrations and pharmacokinetic parameters
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