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)

Kyowa Hakko Kirin Co., Ltd.0 个研究点开始时间: 2010年7月30日最近更新: 2023年10月17日

试验速览

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•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

•- 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

发起方

Kyowa Hakko Kirin Co., Ltd.