Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell Lymphoma

Inclusion criteria

• Subjects with hematologically or pathohistologically diagnosed peripheral T/NK-cell lymphoma
• Subjects who have been positive for CCR4
• Subjects who received one or more chemotherapy regimens
• Subjects who relapse after achieving complete response, uncertain complete response or partial response by the last chemotherapy
• Subjects who have an interval of 4 weeks or more between the last day of the prior therapy and the scheduled day of the first KW-0761 treatment
• Subjects with nodal lesions, extranodal lesions and/or cutaneous lesions
• Subjects who have a performance status of 0 to 2
• Subjects who are negative for HBs antigen and reported as "not detected" for HBV-DNA
• Subjects who are negative for anti-HCV antibody
• Subjects who have normal function of the major organs
• Subjects who have given written voluntary informed consent to participate in the study

Exclusion criteria

• Subjects who underwent transplant therapy such as hematopoietic stem-cell transplantation (Subjects who underwent autologous hematopoietic stem-cell transplantation following chemotherapy will not be excluded)
• Subjects who are known carriers of HIV
• Subjects who have active multiple cancer
• Subjects who have a history of allergic reactions to therapeutic antibodies
• Subjects requiring continuous systemic treatment with steroid
• Subjects who require emergency radiotherapy for treating the symptoms caused by bulky masses at enrollment or who may require such radiotherapy after the start of the study
• Subjects who are pregnant, lactating or of childbearing potential, or who are planning to have children