[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605960":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":33,"responsibleParty":113,"collaborators":31,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":31,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":123,"maxAge":31,"enrollmentInfo":124,"targetDuration":31,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":31,"overallStatus":36,"whyStopped":31,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"BeOne Medicines","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Zanubrutinib","EXPERIMENTAL","Participants will receive 160 mg zanubrutinib orally twice a day until progressive disease, unacceptable toxicity or death, withdrawal of consent, loss to follow-up, or study termination by the sponsor for any reason.",[13],"Drug: Zanubrutinib",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Administered orally",[9],[20,21],"Brukinsa","BGB-3111",[23],{"name":24,"affiliation":25,"role":26},"Study Director","BeiGene","STUDY_DIRECTOR",[28],{"name":24,"role":29,"phone":30,"phoneExt":31,"email":32},"CONTACT","1-877-828-5568",null,"clinicaltrials@beigene.com",[34,48,58,64,74,84,93,103],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":31},"Peking Union Medical College Hospital","RECRUITING","Beijing","Beijing Municipality","100730","China","CN",{"type":43,"coordinates":44},"Point",[45,46],116.39723,39.9075,{"lat":46,"lon":45},{"facility":49,"status":36,"city":50,"state":51,"zip":52,"country":40,"countryCode":41,"cosmosGeoPoint":53,"geoPoint":57,"contacts":31},"Sun Yat Sen University Cancer Center","Guangzhou","Guangdong","510060",{"type":43,"coordinates":54},[55,56],113.25,23.11667,{"lat":56,"lon":55},{"facility":59,"status":36,"city":50,"state":51,"zip":60,"country":40,"countryCode":41,"cosmosGeoPoint":61,"geoPoint":63,"contacts":31},"Nanfang Hospital, Southern Medical University","510515",{"type":43,"coordinates":62},[55,56],{"lat":56,"lon":55},{"facility":65,"status":36,"city":66,"state":67,"zip":68,"country":40,"countryCode":41,"cosmosGeoPoint":69,"geoPoint":73,"contacts":31},"Affiliated Hospital of Hebei University","Baoding","Hebei","071000",{"type":43,"coordinates":70},[71,72],115.46246,38.87288,{"lat":72,"lon":71},{"facility":75,"status":36,"city":76,"state":77,"zip":78,"country":40,"countryCode":41,"cosmosGeoPoint":79,"geoPoint":83,"contacts":31},"Union Hospital of Tongji Medical College, Huazhong University of Science and Technology","Wuhan","Hubei","430022",{"type":43,"coordinates":80},[81,82],114.26667,30.58333,{"lat":82,"lon":81},{"facility":85,"status":36,"city":86,"state":77,"zip":87,"country":40,"countryCode":41,"cosmosGeoPoint":88,"geoPoint":92,"contacts":31},"Yichang Central Peoples Hospital","Yichang","443003",{"type":43,"coordinates":89},[90,91],111.28472,30.71444,{"lat":91,"lon":90},{"facility":94,"status":36,"city":95,"state":96,"zip":97,"country":40,"countryCode":41,"cosmosGeoPoint":98,"geoPoint":102,"contacts":31},"Xiangya Hospital of Central South University","Changsha","Hunan","410008",{"type":43,"coordinates":99},[100,101],112.97087,28.19874,{"lat":101,"lon":100},{"facility":104,"status":36,"city":105,"state":106,"zip":107,"country":40,"countryCode":41,"cosmosGeoPoint":108,"geoPoint":112,"contacts":31},"The First Affiliated Hospital, Zhejiang University School of Medicine","Hangzhou","Zhejiang","310003",{"type":43,"coordinates":109},[110,111],120.16142,30.29365,{"lat":111,"lon":110},{"type":114,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100605960","phase-4-a-study-to-evaluate-the-efficacy-and-safety-of-zanubrutinib-in-chinese-adults-with-treatment-naive-waldenstrm-macroglobulinemia-100605960",false,"NCT07169331","A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naive Waldenström Macroglobulinemia","A Phase 4, Single-Arm, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Patients With Treatment-Naive Waldenström Macroglobulinemia","Inclusion Criteria:\n\n* Clinical and definitive histologic diagnosis of WM. Participant must be treatment-naive.\n* Participant must meet at least 1 criterion for treatment according to consensus panel criteria from the Seventh International Workshop on Waldenström's macroglobulinemia (IWWM).\n* Participant must have measurable disease, as defined by serum immunoglobulin M (IgM) level \\> 0.5 g\u002FdL.\n* Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.\n* Participants must have adequate organ function as indicated by the following laboratory values ≤ 7 days before the first dose of study treatment:\n\n  1. Participants must not have required blood transfusion or growth factor support ≤ 7 days before sample collection at screening for the following:\n\n     * Absolute neutrophil count (ANC) ≥ 0.75 x 10\\^9\u002FL.\n     * Platelets ≥ 50 x 10\\^9\u002FL.\n  2. Creatinine clearance of ≥ 30 ml\u002Fmin as estimated by the Cockcroft-Gault formula.\n  3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN).\n  4. Serum total bilirubin ≤ 2 x ULN (total bilirubin must be \\\u003C 3 x ULN for participants with Gilbert syndrome).\n* Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for at least 1 month after the last dose of zanubrutinib. They must also have a negative urine or serum pregnancy test result ≤ 7 days before the first dose of study treatment.\n\nExclusion Criteria:\n\n* Evidence of disease transformation at the time of study entry.\n* Central nervous system (CNS) involvement by WM. Patients with a history of CNS involvement must undergo magnetic resonance imaging (MRI) and cerebrospinal fluid cytology studies to document no evidence of CNS disease prior to study entry.\n* Evidence of disease transformation at the time of study entry.\n* Participants with any of the following cardiovascular risk factors:\n\n  1. Active cardiac ischemia (eg, cardiac chest pain) ≤ 28 days before first dose of study drug.\n  2. Any history of acute myocardial infarction ≤ 6 months before the first dose of study drug.\n  3. Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV (Appendix 7)≤ 6 months before the first dose of study drug.\n  4. Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before the first dose of study drug.\n  5. Active, clinically significant second-degree atrioventricular block Mobitz II, or third degree atrioventricular block.\n  6. Any history of cerebrovascular accident ≤ 6 months before the first dose of study drug.\n  7. Uncontrolled hypertension that cannot be managed by standard antihypertension medications ≤ 28 days before the first dose of study drug.\n  8. Any episode of syncope or seizure ≤ 28 days before first dose of study drug.\n* At the time of study entry, participants taking warfarin or other vitamin K antagonists.\n* Participants requiring ongoing therapy with strong or moderate cytochrome CYP3A inducers\n* Corticosteroids given with antineoplastic intent within 7 days, or chemotherapy, targeted therapy, or radiation therapy within 4 weeks, or antibody-based therapy within 4 weeks before the start of study drug.\n* Major surgical procedure within 4 weeks before the start of study treatment (bone marrow aspirate and biopsy procedures are not considered major surgical procedures).\n\nNote: Other protocol defined criteria may apply","ALL","18 Years",{"count":125,"type":126},18,"ESTIMATED","INTERVENTIONAL",[129],"PHASE4","The purpose of this study is to measure the efficacy and safety with zanubrutinib in adults with Treatment-Naive (TN) Waldenström Macroglobulinemia (WM). The main objective of this Phase 4 study is to further characterize the efficacy of zanubrutinib in Chinese participants with TN WM in order to fulfill the post-marketing requirements from the National Medical Products Administration (NMPA). Safety data will be collected and evaluated in this study as well.",[132],"Waldenström's Macroglobulinemia","2025-12-15",{"date":135,"type":136},"2025-12-19","ACTUAL",{"date":138,"type":136},"2025-10-17",{"date":140,"type":126},"2028-10-31",{"name":25,"class":6},8]