nctId: NCT06285370 id: 0761-CN001 id: CTR20230672 type: OTHER domain: National Medical Products Administration briefTitle: A Study to Evaluate the Efficacy and Safety of KW-0761 in Chinese Subjects With Mycosis Fungoides or Sézary Syndrome Previously Treated With Systemic Therapy overallStatus: RECRUITING date: 2023-05-29 date: 2025-10-31 date: 2026-01-31 date: 2024-02-29 date: 2024-04-29 name: Kyowa Kirin China Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: The purpose of the study is to evaluate the efficacy and safety of mogamulizumab (KW-0761) in chinese subjects with mycosis fungoides or sézary syndrome previously treated with systemic therapy conditions: Cutaneous T-Cell Lymphoma studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is an open-label, multicenter, single arm study. primaryPurpose: TREATMENT masking: NONE maskingDescription: No Masking count: 20 type: ESTIMATED name: Mogamulizumab measure: Overall Response Rate measure: Skin disease response rate; measure: Lymth nodes response rate measure: Visceral metastases response rate; measure: Blood disease response rate; measure: Progression Free Survival measure: Duration of response (DOR) measure: Time to response (TTR) measure: Response rate of lymph node evaluated by Lugano 2014. measure: Response rate of viscera evaluated by Lugano 2014 criteria. measure: To evaluate pharmacokinetics (plasma mogamulizumab concentration) of mogamulizumab. measure: To evaluate immunogenicity (anti-mogamulizumab antibody) of mogamulizumab. measure: To evaluate the effects of skin disease on health-related Quality of Life (HRQoL) -Skindex 29. measure: The incidence and frequency of treatment-related adverse events (TEAEs) and drug-related TEAEs as assessed by CTCAE v5.0. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Hospital Chinese Academy of Medical Sciences status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 100021 country: China name: Yuankai Shi role: CONTACT phone: 13701251865 email: syuankai@cicams.an.cn name: Yuankai Shi role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Peking University First Hospital, Department of Dermatology and Venereology status: RECRUITING city: Beijing state: Beijing zip: 100034 country: China name: Ping Tu role: CONTACT phone: 13021262219 email: tup0207@sina.com name: Ping Tu role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Sun Yat-sen University Cancer Center, Department of Medical Oncology status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong zip: 510060 country: China name: Huiqiang Huang role: CONTACT phone: 13808885154 email: huang_sysu@163.com name: Huiqiang Huang role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: The 2nd Affiliated Hospital of Harbin Medical University status: NOT_YET_RECRUITING city: Harbin state: Heilongjiang zip: 150001 country: China name: Yuzhen Li role: CONTACT phone: 13936367628 email: liyuzhenchina@126.com name: Yuzhen Li role: PRINCIPAL_INVESTIGATOR lat: 45.75 lon: 126.65 facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology status: RECRUITING city: Wuhan state: Hubei country: China name: Liling Zhang role: CONTACT phone: 15871725926 email: lily1228@sina.com name: Liling Zhang role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 facility: Hunan Cancer Hospital status: NOT_YET_RECRUITING city: Changsha state: Hunan zip: 410031 country: China name: Hui Zhou role: CONTACT phone: 13975879796 email: zhouhui9403@126.com name: Hui Zhou role: PRINCIPAL_INVESTIGATOR lat: 28.19874 lon: 112.97087 facility: The Affiliated Hospital of Inner Mongolia Medical University status: NOT_YET_RECRUITING city: Hohhot state: Inner Mongolia zip: 010000 country: China name: Da Gao role: CONTACT phone: 13947130473 email: gaoda72@163.com name: Da Gao role: PRINCIPAL_INVESTIGATOR lat: 40.81056 lon: 111.65222 facility: The First Hospital of China Medical University status: NOT_YET_RECRUITING city: Shenyang state: Liaoning zip: 110002 country: China name: Xinghua Gao role: CONTACT phone: 13940152467 email: gaobarry@hotmail.com name: Xinghua Gao role: PRINCIPAL_INVESTIGATOR lat: 41.79222 lon: 123.43278 facility: Zhongshan Hospital Fudan University status: NOT_YET_RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Peng Liu role: CONTACT phone: 1581725926 email: liu.peng@zshospital.sh.cn name: Peng Liu role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 facility: West China Hospital, Sichuan University status: NOT_YET_RECRUITING city: Chengdu state: Sichuan zip: 610044 country: China name: Lin Wang role: CONTACT phone: 18980601701 email: LKZWL@126.com name: Lin Wang role: PRINCIPAL_INVESTIGATOR name: Liqun Zou role: PRINCIPAL_INVESTIGATOR lat: 30.66667 lon: 104.06667 facility: ZheJiang Cancer Hospital status: RECRUITING city: Hangzhou state: Zhejiang zip: 310005 country: China name: Haiyan Yang role: CONTACT phone: 18960860662 email: yanghaiyantb@126.com name: Haiyan Yang role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 facility: First Affiliated Hospital of Zhengzhou University status: NOT_YET_RECRUITING city: Henan state: Zhengzhou zip: 450052 country: China name: Xinhua Wang role: CONTACT phone: 15036115299 email: xinwang512@163.com name: Xinhua Wang role: PRINCIPAL_INVESTIGATOR hasResults: False