[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569664":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":43,"responsibleParty":217,"collaborators":40,"id":219,"slug":220,"hasResults":221,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":40,"eligibilityCriteria":225,"healthyVolunteers":221,"sex":226,"minAge":227,"maxAge":40,"enrollmentInfo":228,"targetDuration":40,"studyType":231,"phases":232,"briefSummary":235,"conditions":236,"keywords":241,"overallStatus":46,"whyStopped":40,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":253},{"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},[44,58,68,78,88,98,108,120,130,140,149,159,168,179,188,197,208],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":40},"Moffitt Cancer Center","RECRUITING","Tampa","Florida","33612-9496","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-82.45843,27.94752,{"lat":56,"lon":55},{"facility":59,"status":46,"city":60,"state":61,"zip":62,"country":50,"countryCode":51,"cosmosGeoPoint":63,"geoPoint":67,"contacts":40},"Fort Wayne Medical Oncology and Hematology","Fort Wayne","Indiana","46804",{"type":53,"coordinates":64},[65,66],-85.12886,41.1306,{"lat":66,"lon":65},{"facility":69,"status":46,"city":70,"state":71,"zip":72,"country":50,"countryCode":51,"cosmosGeoPoint":73,"geoPoint":77,"contacts":40},"The University of Kansas Cancer Center","Westwood","Kansas","66205-2003",{"type":53,"coordinates":74},[75,76],-94.6169,39.04056,{"lat":76,"lon":75},{"facility":79,"status":46,"city":80,"state":81,"zip":82,"country":50,"countryCode":51,"cosmosGeoPoint":83,"geoPoint":87,"contacts":40},"Dana Farber Cancer Institute","Boston","Massachusetts","02215-5418",{"type":53,"coordinates":84},[85,86],-71.05977,42.35843,{"lat":86,"lon":85},{"facility":89,"status":46,"city":90,"state":91,"zip":92,"country":50,"countryCode":51,"cosmosGeoPoint":93,"geoPoint":97,"contacts":40},"Washington University School of Medicine","St Louis","Missouri","63110-1010",{"type":53,"coordinates":94},[95,96],-90.19789,38.62727,{"lat":96,"lon":95},{"facility":99,"status":46,"city":100,"state":101,"zip":102,"country":50,"countryCode":51,"cosmosGeoPoint":103,"geoPoint":107,"contacts":40},"Fred Hutchinson Cancer Research Center","Seattle","Washington","98109-4433",{"type":53,"coordinates":104},[105,106],-122.33207,47.60621,{"lat":106,"lon":105},{"facility":109,"status":46,"city":110,"state":111,"zip":112,"country":113,"countryCode":114,"cosmosGeoPoint":115,"geoPoint":119,"contacts":40},"Blacktown Cancer and Haematology Centre","Blacktown","New South Wales","NSW 2148","Australia","AU",{"type":53,"coordinates":116},[117,118],150.91667,-33.76667,{"lat":118,"lon":117},{"facility":121,"status":46,"city":122,"state":123,"zip":124,"country":113,"countryCode":114,"cosmosGeoPoint":125,"geoPoint":129,"contacts":40},"Genesiscare St Andrews","Adelaide","South Australia","SA 5000",{"type":53,"coordinates":126},[127,128],138.59863,-34.92866,{"lat":128,"lon":127},{"facility":131,"status":46,"city":132,"state":133,"zip":134,"country":113,"countryCode":114,"cosmosGeoPoint":135,"geoPoint":139,"contacts":40},"Cabrini Hospital Malvern","Malvern","Victoria","VIC 3144",{"type":53,"coordinates":136},[137,138],145.02811,-37.86259,{"lat":138,"lon":137},{"facility":141,"status":46,"city":142,"state":133,"zip":143,"country":113,"countryCode":114,"cosmosGeoPoint":144,"geoPoint":148,"contacts":40},"The Alfred Hospital","Melbourne","VIC 3004",{"type":53,"coordinates":145},[146,147],144.96332,-37.814,{"lat":147,"lon":146},{"facility":150,"status":46,"city":151,"state":152,"zip":153,"country":113,"countryCode":114,"cosmosGeoPoint":154,"geoPoint":158,"contacts":40},"Rockingham Hospital","Cooloongup","Western Australia","WA 6168",{"type":53,"coordinates":155},[156,157],115.78,-32.295,{"lat":157,"lon":156},{"facility":160,"status":46,"city":161,"state":152,"zip":162,"country":113,"countryCode":114,"cosmosGeoPoint":163,"geoPoint":167,"contacts":40},"Linear Clinical Research","Nedlands","WA 6009",{"type":53,"coordinates":164},[165,166],115.8073,-31.98184,{"lat":166,"lon":165},{"facility":169,"status":46,"city":170,"state":40,"zip":171,"country":172,"countryCode":173,"cosmosGeoPoint":174,"geoPoint":178,"contacts":40},"Chu Dijon","Dijon","21000","France","FR",{"type":53,"coordinates":175},[176,177],5.01391,47.31344,{"lat":177,"lon":176},{"facility":180,"status":46,"city":181,"state":40,"zip":182,"country":172,"countryCode":173,"cosmosGeoPoint":183,"geoPoint":187,"contacts":40},"Chu Montpellier Hopital Saint Eloi","Montpellier","34090",{"type":53,"coordinates":184},[185,186],3.87635,43.61093,{"lat":186,"lon":185},{"facility":189,"status":46,"city":190,"state":40,"zip":191,"country":172,"countryCode":173,"cosmosGeoPoint":192,"geoPoint":196,"contacts":40},"Iuct Oncopole","Toulouse","31100",{"type":53,"coordinates":193},[194,195],1.44367,43.60426,{"lat":195,"lon":194},{"facility":198,"status":46,"city":199,"state":40,"zip":200,"country":201,"countryCode":202,"cosmosGeoPoint":203,"geoPoint":207,"contacts":40},"Queen Elizabeth Hospital","Birmingham","B15 2TH","United Kingdom","UK",{"type":53,"coordinates":204},[205,206],-1.89983,52.48142,{"lat":206,"lon":205},{"facility":209,"status":46,"city":210,"state":40,"zip":211,"country":201,"countryCode":202,"cosmosGeoPoint":212,"geoPoint":216,"contacts":40},"St Jamess University Hospital","Leeds","LS9 7TF",{"type":53,"coordinates":213},[214,215],-1.54785,53.79648,{"lat":215,"lon":214},{"type":218,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100569664","a-study-to-investigate-the-safety-of-novel-dose-ramp-up-schedules-when-initiating-sonrotoclax-in-participants-treated-for-blood-cancers-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":229,"type":230},258,"ESTIMATED","INTERVENTIONAL",[233,234],"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.",[237,238,239,240],"Chronic Lymphocytic Leukemia","CLL","Mantle Cell Lymphoma","MCL",[242,243],"CLL previously untreated","Hematological Malignancies","2026-08-06",{"date":246,"type":247},"2026-08-10","ACTUAL",{"date":249,"type":247},"2025-01-23",{"date":251,"type":230},"2032-11-30",{"name":5,"class":6},17]