[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05640102":3,"trial-entities:NCT05640102":147,"trial-summary:NCT05640102":151},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":17,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":37,"secondary_outcomes":42,"sex":55,"minimum_age":56,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":57,"std_ages":69,"locations":72,"central_contacts":136,"overall_officials":142,"references":145,"see_also_links":146},"NCT05640102","BGB-3111-402","Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia","A Phase 4, Observational Study Evaluating the Efficacy and Safety of the Bruton Tyrosine Kinase (BTK) Inhibitor Zanubrutinib in Patients With Waldenström Macroglobulinemia","RECRUITING","2027-12","2026-08","2026-08-07","2023-03-03","BeiGene","INDUSTRY",false,"This is a hybrid (retrospective and prospective) non-interventional registry study to further describe the clinical profile of zanubrutinib in Waldenström macroglobulinemia (WM) participants with and without specific mutations and from racial and ethnic minority groups. Data collected from this registry study will be used to better understand the clinical benefit and safety of zanubrutinib for the treatment of participants in these populations.",null,[19],"Waldenstrom Macroglobulinemia",[],"OBSERVATIONAL",[],{"count":24,"type":25},111,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":34},"DRUG","Zanubrutinib","Dosing and treatment duration are at the discretion of the prescribing physician and in accordance with local labeling",[32,33],"Cohort 1: MYD88 L265P mutation","Cohort 2: Non-L265P MYD88 mutation(s) and MYD88 wildtype",[35,36],"BGB-3111","Brukinsa",[38],{"measure":39,"description":40,"timeFrame":41},"Major Response Rate (MRR)","MRR is defined as the proportion of participants achieving either complete response (CR), very good partial response (VGPR), or partial response (PR) as determined by the investigator using an adaptation of the response criteria updated at the Sixth International Workshop on WM (IWWM)","Up to approximately 4 years",[43,47,50,53],{"measure":44,"description":45,"timeFrame":46},"VGPR+ Rate","VGPR+ rate is defined as the proportion of participants achieving either CR or VGPR","Up to approximately 5 years",{"measure":48,"description":49,"timeFrame":46},"Overall Response Rate (ORR)","ORR is defined as the proportion of participants achieving either CR, VGPR, PR, or minor response (MR)",{"measure":51,"description":52,"timeFrame":46},"Duration of Response (DOR)","DOR is defined as the time from the first determination of response (CR, VGPR, or PR) until first documentation of or death, whichever comes first",{"measure":54,"timeFrame":46},"Number of Participants with Treatment-emergent Adverse Events","ALL","18 Years",{"inclusion":58,"exclusion":63,"raw_text":68},[59,60,61,62],"Clinical and definitive histologic diagnosis of WM","Measurable disease, as defined by a serum immunoglobulin M (IgM) level \\> 0.5 g\u002FdL at the time of zanubrutinib initiation","Started treatment with zanubrutinib, has been treated with zanubrutinib, or is planned to be prescribed zanubrutinib for the treatment of WM","Bone marrow specimens with central MYD88 test results of:",[64,65,66,67],"Evidence of disease transformation before the first dose of zanubrutinib","Evidence of other non-Hodgkin Lymphoma (NHL) subtypes","Prior or concurrent active malignancy ≤ 2 years before the first dose of zanubrutinib, except for malignancies that, in the investigator's opinion, will not obscure the interpretation of safety or efficacy results","Concurrent participation in another therapeutic clinical study while receiving zanubrutinib, although the participant may be eligible depending on the status of the interventional study after discussion with the Medical Monitor or designee on an individual basis","Inclusion Criteria:\n\n* Clinical and definitive histologic diagnosis of WM\n* Measurable disease, as defined by a serum immunoglobulin M (IgM) level \\> 0.5 g\u002FdL at the time of zanubrutinib initiation\n* Started treatment with zanubrutinib, has been treated with zanubrutinib, or is planned to be prescribed zanubrutinib for the treatment of WM\n* Bone marrow specimens with central MYD88 test results of:\n\n  1. Cohort 1: MYD88 L265P mutation; enrollment of TN participants will be stopped in each racial and ethnic participant group when the required numbers of participants in the group are met\n  2. Cohort 2: non-L265P MYD88 mutation(s) and MYD88WT\n\nExclusion Criteria:\n\n* Evidence of disease transformation before the first dose of zanubrutinib\n* Evidence of other non-Hodgkin Lymphoma (NHL) subtypes\n* Prior or concurrent active malignancy ≤ 2 years before the first dose of zanubrutinib, except for malignancies that, in the investigator's opinion, will not obscure the interpretation of safety or efficacy results\n* Concurrent participation in another therapeutic clinical study while receiving zanubrutinib, although the participant may be eligible depending on the status of the interventional study after discussion with the Medical Monitor or designee on an individual basis",[70,71],"ADULT","OLDER_ADULT",[73,82,89,97,104,111,120,128],{"facility":74,"status":8,"city":75,"state":76,"zip":77,"country":78,"geoPoint":79},"Clearview Cancer Institute","Huntsville","Alabama","35805-2606","United States",{"lat":80,"lon":81},34.7304,-86.58594,{"facility":83,"status":8,"city":84,"state":76,"zip":85,"country":78,"geoPoint":86},"South Alabama Medical Science Foundation Mitchell Cancer Institute","Mobile","36604-1405",{"lat":87,"lon":88},30.69436,-88.04305,{"facility":90,"status":8,"city":91,"state":92,"zip":93,"country":78,"geoPoint":94},"City of Hope National Medical Center","Duarte","California","91010-3012",{"lat":95,"lon":96},34.13945,-117.97729,{"facility":98,"status":8,"city":99,"state":92,"zip":100,"country":78,"geoPoint":101},"Los Angeles Cancer Network (Lacn)","Glendale","91204-3640",{"lat":102,"lon":103},34.14251,-118.25508,{"facility":105,"status":8,"city":106,"state":92,"zip":107,"country":78,"geoPoint":108},"Eisenhower Medical Center, Lucy Curci Cancer Center","Rancho Mirage","92270-3221",{"lat":109,"lon":110},33.73974,-116.41279,{"facility":112,"status":113,"city":114,"state":115,"zip":116,"country":78,"geoPoint":117},"Hattiesburg Hematology and Oncology Clinic","ACTIVE_NOT_RECRUITING","Hattiesburg","Mississippi","39401-7233",{"lat":118,"lon":119},31.32712,-89.29034,{"facility":121,"status":8,"city":122,"state":123,"zip":124,"country":78,"geoPoint":125},"Comprehensive Cancer Centers of Nevada","Las Vegas","Nevada","89169-3321",{"lat":126,"lon":127},36.17497,-115.13722,{"facility":129,"status":113,"city":130,"zip":131,"country":132,"geoPoint":133},"Pan American Oncology Trials, Llc","Rio Piedras","00935","Puerto Rico",{"lat":134,"lon":135},18.39745,-66.04989,[137],{"name":138,"role":139,"phone":140,"email":141},"Study Director","CONTACT","1-877-828-5568","clinicaltrials@beigene.com",[143],{"name":138,"affiliation":13,"role":144},"STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":148,"biomarkers":149},[19],[150],"MYD88 Gene",{"nct_id":4,"found":152,"summary":153,"prompt_version":163},true,{"design":154,"status":155,"heading":156,"summary":157,"follow_up":158,"word_count":159,"commitments":160,"compensation":161,"drugs_mentioned":162},"This is an observational study, meaning researchers will collect information about your treatment as prescribed by your doctor. It is a hybrid study, looking at past and future information, and is not a traditional clinical trial where treatments are assigned.","completed","Observational Study of Zanubrutinib for Waldenström Macroglobulinemia","This study is looking at how well and how safely zanubrutinib works for people with Waldenström Macroglobulinemia (WM), a rare type of cancer affecting white blood cells. Researchers want to understand its effects in different groups, including those with specific genetic changes (mutations) and from diverse racial and ethnic backgrounds. You might be able to join if you have WM, have a certain level of a protein called serum immunoglobulin M (IgM), and are already taking or planning to take zanubrutinib. The main goal is to see how many people have a major response to the treatment over about four years. The study status is currently unclear, and it plans to include 111 participants.","The primary outcome, Major Response Rate, will be measured for up to approximately 4 years.",114,"Dosing and treatment duration are decided by your doctor. The study will collect data from your medical records.","Not stated in the trial record.",[29],"v2"]