[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569664":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":43,"responsibleParty":214,"collaborators":40,"id":216,"slug":40,"hasResults":217,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":40,"eligibilityCriteria":221,"healthyVolunteers":217,"sex":222,"minAge":223,"maxAge":40,"enrollmentInfo":224,"targetDuration":40,"studyType":227,"phases":228,"briefSummary":231,"conditions":232,"keywords":237,"overallStatus":109,"whyStopped":40,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":249},{"fullName":5,"class":6},"BeOne Medicines","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Arms: 1A,1B and 2A: Zanubrutinib + Sonrotoclax for TN CLL","EXPERIMENTAL","Participants will receive zanubrutinib alone, followed by a combination with sonrotoclax initiated with a ramp-up according to each schedule defined in the protocol. The total treatment duration is of 15 cycles of 28 days (including the phase of sonrotoclax dose ramp-up)",[13,14],"Drug: Sonrotoclax","Drug: Zanubrutinib",{"label":16,"type":10,"description":17,"interventionNames":18},"Arms: 1C and 2B: Zanubrutinib + Sonrotoclax for R\u002FR MCL","Participants will receive zanubrutinib alone, followed by a combination with sonrotoclax initiated with a ramp-up according to each schedule defined in the protocol, for a total of 27 cycles of 28 days (including the phase of sonrotoclax ramp-up), then will continue on zanubrutinib alone until progression of their disease or other treatment discontinuation criteria.",[13,14],[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Sonrotoclax","Administered orally",[9,16],[26],"BGB-11417",{"type":21,"name":28,"description":23,"armGroupLabels":29,"otherNames":30},"Zanubrutinib",[9,16],[31],"BGB-3111",[33],{"name":34,"affiliation":5,"role":35},"Study Director","STUDY_DIRECTOR",[37,42],{"name":34,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","1.877.828.5568",null,"clinicaltrials@beonemed.com",{"name":34,"role":38,"phone":40,"phoneExt":40,"email":40},[44,57,67,77,87,97,107,119,129,139,148,158,167,177,186,195,205],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":40},"Moffitt Cancer Center","ACTIVE_NOT_RECRUITING","Tampa","Florida","33612-9496","United States",{"type":52,"coordinates":53},"Point",[54,55],-82.45843,27.94752,{"lat":55,"lon":54},{"facility":58,"status":46,"city":59,"state":60,"zip":61,"country":50,"cosmosGeoPoint":62,"geoPoint":66,"contacts":40},"Fort Wayne Medical Oncology and Hematology","Fort Wayne","Indiana","46804",{"type":52,"coordinates":63},[64,65],-85.12886,41.1306,{"lat":65,"lon":64},{"facility":68,"status":46,"city":69,"state":70,"zip":71,"country":50,"cosmosGeoPoint":72,"geoPoint":76,"contacts":40},"The University of Kansas Cancer Center","Westwood","Kansas","66205-2003",{"type":52,"coordinates":73},[74,75],-94.6169,39.04056,{"lat":75,"lon":74},{"facility":78,"status":46,"city":79,"state":80,"zip":81,"country":50,"cosmosGeoPoint":82,"geoPoint":86,"contacts":40},"Dana Farber Cancer Institute","Boston","Massachusetts","02215-5418",{"type":52,"coordinates":83},[84,85],-71.05977,42.35843,{"lat":85,"lon":84},{"facility":88,"status":46,"city":89,"state":90,"zip":91,"country":50,"cosmosGeoPoint":92,"geoPoint":96,"contacts":40},"Washington University School of Medicine","St Louis","Missouri","63110-1010",{"type":52,"coordinates":93},[94,95],-90.19789,38.62727,{"lat":95,"lon":94},{"facility":98,"status":46,"city":99,"state":100,"zip":101,"country":50,"cosmosGeoPoint":102,"geoPoint":106,"contacts":40},"Fred Hutchinson Cancer Research Center","Seattle","Washington","98109-4433",{"type":52,"coordinates":103},[104,105],-122.33207,47.60621,{"lat":105,"lon":104},{"facility":108,"status":109,"city":110,"state":111,"zip":112,"country":113,"cosmosGeoPoint":114,"geoPoint":118,"contacts":40},"Blacktown Cancer and Haematology Centre","RECRUITING","Blacktown","New South Wales","NSW 2148","Australia",{"type":52,"coordinates":115},[116,117],150.91667,-33.76667,{"lat":117,"lon":116},{"facility":120,"status":109,"city":121,"state":122,"zip":123,"country":113,"cosmosGeoPoint":124,"geoPoint":128,"contacts":40},"Genesiscare St Andrews","Adelaide","South Australia","SA 5000",{"type":52,"coordinates":125},[126,127],138.59863,-34.92866,{"lat":127,"lon":126},{"facility":130,"status":109,"city":131,"state":132,"zip":133,"country":113,"cosmosGeoPoint":134,"geoPoint":138,"contacts":40},"Cabrini Hospital Malvern","Malvern","Victoria","VIC 3144",{"type":52,"coordinates":135},[136,137],145.02811,-37.86259,{"lat":137,"lon":136},{"facility":140,"status":109,"city":141,"state":132,"zip":142,"country":113,"cosmosGeoPoint":143,"geoPoint":147,"contacts":40},"The Alfred Hospital","Melbourne","VIC 3004",{"type":52,"coordinates":144},[145,146],144.96332,-37.814,{"lat":146,"lon":145},{"facility":149,"status":109,"city":150,"state":151,"zip":152,"country":113,"cosmosGeoPoint":153,"geoPoint":157,"contacts":40},"Rockingham Hospital","Cooloongup","Western Australia","WA 6168",{"type":52,"coordinates":154},[155,156],115.78,-32.295,{"lat":156,"lon":155},{"facility":159,"status":109,"city":160,"state":151,"zip":161,"country":113,"cosmosGeoPoint":162,"geoPoint":166,"contacts":40},"Linear Clinical Research","Nedlands","WA 6009",{"type":52,"coordinates":163},[164,165],115.8073,-31.98184,{"lat":165,"lon":164},{"facility":168,"status":46,"city":169,"state":40,"zip":170,"country":171,"cosmosGeoPoint":172,"geoPoint":176,"contacts":40},"Chu Dijon","Dijon","21000","France",{"type":52,"coordinates":173},[174,175],5.01391,47.31344,{"lat":175,"lon":174},{"facility":178,"status":46,"city":179,"state":40,"zip":180,"country":171,"cosmosGeoPoint":181,"geoPoint":185,"contacts":40},"Chu Montpellier Hopital Saint Eloi","Montpellier","34090",{"type":52,"coordinates":182},[183,184],3.87635,43.61093,{"lat":184,"lon":183},{"facility":187,"status":46,"city":188,"state":40,"zip":189,"country":171,"cosmosGeoPoint":190,"geoPoint":194,"contacts":40},"Iuct Oncopole","Toulouse","31100",{"type":52,"coordinates":191},[192,193],1.44367,43.60426,{"lat":193,"lon":192},{"facility":196,"status":46,"city":197,"state":40,"zip":198,"country":199,"cosmosGeoPoint":200,"geoPoint":204,"contacts":40},"Queen Elizabeth Hospital","Birmingham","B15 2TH","United Kingdom",{"type":52,"coordinates":201},[202,203],-1.89983,52.48142,{"lat":203,"lon":202},{"facility":206,"status":46,"city":207,"state":40,"zip":208,"country":199,"cosmosGeoPoint":209,"geoPoint":213,"contacts":40},"St Jamess University Hospital","Leeds","LS9 7TF",{"type":52,"coordinates":210},[211,212],-1.54785,53.79648,{"lat":212,"lon":211},{"type":215,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100569664",false,"NCT06697184","A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.","A Phase 1\u002F2 Open-label Study to Investigate the Safety of Sonrotoclax Ramp-up Schedule(s) in Adult Patients With Hematological Malignancies.","Inclusion Criteria:\n\n1. Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.\n2. Adequate organ function and no very recent transfusion or blood growth factor\n3. 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 ≥ 7 days after the last dose of sonrotoclax or 1 month after the last dose of zanubrutinib, whichever is later.\n\n   Only for participants with Chronic Lymphocytic Leukemia (CLL):\n4. Confirmed diagnosis of CLL, based on Hallek et al 2018, and requiring treatment due to certain features of their disease\n5. At least 1 measurable lesion based on computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) and no history of prolymphocytic leukemia or Richter's transformation.\n\n   Only for participants with Mantle cell lymphoma (MCL):\n6. Historically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HEAM5) or based on International Consensus Classification (ICC).\n7. Relapsed or refractory to the last line of therapy and have received at least 1 prior line of systemic therapy. Note: A line of therapy is considered ≥ 2 consecutive cycles of a systemic anticancer regimen. Patients with prior BTKi therapy should not have progressed during treatment or relapsed within 12 months after BTKi discontinuation.\n8. Measurable disease defined as ≥ 1 nodal lesion that is \\> 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is \\> 1 cm in longest diameter.\n\nExclusion Criteria:\n\n1. Participants unable to comply with the requirements of the protocol\n2. Serologic status reflecting active viral hepatitis B virus (HBV) or hepatitis C virus (HCV) infection\n3. Positive HIV serology (HIVAb) status unless certain conditions are met.\n4. Participants with any major surgical procedure ≤ 28 days before first dose of study treatment\n5. Prior systemic treatment for the CLL\n6. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment\n7. Prior exposure to a BCL-2 inhibitor\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":225,"type":226},258,"ESTIMATED","INTERVENTIONAL",[229,230],"PHASE1","PHASE2","The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.",[233,234,235,236],"Chronic Lymphocytic Leukemia","CLL","Mantle Cell Lymphoma","MCL",[238,239],"CLL previously untreated","Hematological Malignancies","2026-06-05",{"date":242,"type":243},"2026-06-08","ACTUAL",{"date":245,"type":243},"2025-01-23",{"date":247,"type":226},"2032-11-30",{"name":5,"class":6},17]