Phase II study of KW-0761 in subjects with CCR4-positive peripheral T/NK-cell lymphoma

Kyowa Hakko Kirin Co., Ltd.0 个研究点开始时间: 2010年8月31日最近更新: 2023年10月17日

试验速览

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•Subjects with hematologically or pathohistologically diagnosed peripheral T/NK-cell lymphoma
•- Subjects who are 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

•- 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

发起方

Kyowa Hakko Kirin Co., Ltd.