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