Phase II 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