Multicenter, Randomized, Open-label, Parallel-group Study to Compare mLSG15 + KW-0761 to mLSG15 in Subjects With CCR4-positive Adult T-cell Leukemia-lymphoma (Untreated Primary Disease)
Inclusion Criteria:
- Subjects who have been positive for serum anti-human T-cell lymphotropic virus type I
antibody
- Subjects with hematologically or pathohistologically confirmed as peripheral lymphoid
tumor which surface antigen analysis has identified to be of T-cell origin
- Subjects who have been classified into acute subtype, the lymphoma subtype or chronic
subtype with poor prognostic factors
- Subjects who have been positive for CCR4 by CCR4 expression analysis
- Subjects who have never been treated for adult T-cell leukemia-lymphoma
- Subjects who have presented enlarged lymph nodes, tumor nodules in extranodal organs,
abnormal lymphocytes in peripheral blood or cutaneous lesions
- Subjects with a performance status of 0 to 2
- Subjects who have been negative for HBs antigen and anti-HCV antibody
- Subjects who have given written voluntary informed consent to participate in the
study
Exclusion Criteria:
- Subjects who are scheduled for transplant therapy such as hematopoietic stem-cell
transplantation
- Subjects who had myocardial infarction within 12 months before study enrollment or
who have cardiac disease that may worsen during treatment with doxorubicin
- Subjects who have been positive for anti-HIV antibody
- Subjects with active multiple cancer
- Subjects with a history of allergic reactions to therapeutic antibodies
- Subjects who require emergency radiotherapy for treating the symptoms caused by bulky
masses 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