[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632089":3},{"organization":4,"outcomesModule":7,"designInfo":59,"detailedDescription":65,"studyPopulation":58,"armGroups":66,"interventions":85,"overallOfficials":58,"centralContacts":94,"locations":100,"responsibleParty":468,"collaborators":470,"id":473,"slug":474,"hasResults":475,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":479,"eligibilityCriteria":480,"healthyVolunteers":475,"sex":481,"minAge":482,"maxAge":482,"enrollmentInfo":483,"targetDuration":58,"studyType":486,"phases":487,"briefSummary":489,"conditions":490,"keywords":492,"overallStatus":232,"whyStopped":58,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":509},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":58},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"DOSRI- Number of participants with adverse events (AEs) and Serious Adverse Events (SAEs)","To assess the safety and tolerability of SC surovatamig as consolidation therapy using dose optimisation in CLL\u002FSLL participants with uIGHV. Also, to determine the RP3D of SC surovatamig monotherapy as consolidation therapy in CLL\u002FSLL participants with uIGHV.","Up to 5 years",{"measure":14,"description":15,"timeFrame":16},"Phase III- Progression Free Survival (PFS)","PFS is defined as the time from date of randomisation until disease progression or death due to any cause, whichever occur first based on International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria, as assessed by independent review committee (IRC).","Until disease progression or death (up to 5 years)",{"measure":18,"description":11,"timeFrame":12},"DOSRI- Number of participants with study intervention discontinuations, dose reductions and dose delays due to AEs",[20,23,26,29,32,35,39,43,46,48,52,55],{"measure":21,"description":22,"timeFrame":12},"Objective Response Rate (ORR)","ORR is defined as the proportion of participants achieving either a partial response (PR) or complete response (CR)\u002Fcomplete response with incomplete haematological recovery (CRi) based on response criteria iwCLL 2018, as assessed by IRC or investigator at any point during therapy\u002Fobservation.",{"measure":24,"description":25,"timeFrame":12},"Complete Response rate (CR rate)","CR rate is defined as the proportion of participants achieving a CR or CRi as best response based on response criteria for iwCLL 2018.",{"measure":27,"description":28,"timeFrame":12},"Duration of response (DoR)","The DoR is defined as the time from the date of first documented response until date of documented progression based on response criteria for iwCLL 2018.",{"measure":30,"description":31,"timeFrame":16},"DOSRI- PFS","PFS for Safety Run-in phase is defined as the time from first dose until the date of documented progression or death due to any cause whichever comes first, based on iwCLL 2018 criteria.",{"measure":33,"description":34,"timeFrame":12},"Overall Survival (OS)","OS is defined as the time from first dose until death due to any cause.",{"measure":36,"description":37,"timeFrame":38},"Serum concentrations of Surovatamig","To characterise the serum concentration of SC surovatamig as consolidation therapy in CLL\u002FSLL participants with uIGHV.","At pre-defined intervals from date offirst dose (C1D1) up to 30 days from last dose (approximately 5 years)",{"measure":40,"description":41,"timeFrame":42},"Maximum concentration observed (Cmax)","To characterise the pharmacokinetics (PK) of SC surovatamig as consolidation therapy in CLL\u002FSLL participants with uIGHV.","At pre-defined intervals from date of first dose up to 30 days from last dose (approximately 5 years)",{"measure":44,"description":45,"timeFrame":42},"Time to Maximum Concentration (tmax)","To characterise the PK of SC surovatamig as consolidation therapy in CLL\u002FSLL participants with uIGHV.",{"measure":47,"description":45,"timeFrame":42},"Trough concentration (Ctrough)",{"measure":49,"description":50,"timeFrame":51},"Number of participants with Anti-drug antibodies (ADA)","DOSRI- To evaluate the immunogenicity of SC surovatamig as consolidation therapy in CLL\u002FSLL participants with uIGHV.\n\nPhase III- To determine the immunogenicity of SC surovatamig in CLL\u002FSLL participants with uIGHV.","At predefined intervals from the date of first dose to approximately 5 years",{"measure":53,"description":54,"timeFrame":16},"Phase III- PFS","PFS is defined as the time from date of randomisation until disease progression or death due to any cause , whichever comes first based on iwCLL 2018 criteria, as assessed by investigator.",{"measure":56,"description":57,"timeFrame":12},"Phase III- Number of participants with AEs and SAEs","To assess safety and tolerability of SC surovatamig compared to observation in CLL\u002FSLL participants with uIGHV.",null,{"allocation":60,"interventionModel":61,"interventionModelDescription":58,"primaryPurpose":62,"observationalModel":58,"timePerspective":58,"maskingInfo":63},"RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":64,"maskingDescription":58,"whoMasked":58},"NONE","This is a Phase III global, randomised, open-label, multicentre study. The study will consist of 2 sequential parts- the Dose Optimisation and Safety Run-in part and the Phase-III part.\n\nDuring the dose optimisation and safety run-in part, Surovatamig will be initiated in 2 dose levels. This part will help to determine the recommended phase III dose (RP3D) of Surovatamig to be used in Phase III part. Phase III would comprise of 2 arms, Arm A where the Surovatamig dose (RP3D) will be administered as a consolidation therapy (post standard of care \\[SOC\\] induction therapy) and Arm B where participants will be observed. In Phase 3 participants will be randomized in a 1:1 ratio to Arm A or Arm B.",[67,73,77,81],{"label":68,"type":69,"description":70,"interventionNames":71},"Dose Optimisation and Safety run-in (DOSRI)- Surovatamig Dose 1","EXPERIMENTAL","Participants will receive Surovatamig Dose 1 subcutaneously (SC) for 6 cycles (each cycle is 28 days in length).",[72],"Drug: Surovatamig",{"label":74,"type":69,"description":75,"interventionNames":76},"DOSRI-Surovatamig Dose 2","Participants will receive Surovatamig Dose 2 SC for 6 cycles (each cycle is 28 days in length).",[72],{"label":78,"type":69,"description":79,"interventionNames":80},"Phase III-Arm A: Surovatamig SC","Participants will receive Surovatamig at RP3D subcutaneously for 6 cycles (each cycle is 28 days in length).",[72],{"label":82,"type":83,"description":84,"interventionNames":58},"Phase III-Arm B: Observation","NO_INTERVENTION","Participants will undergo observation for 24 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5G2","Canada","CA",{"type":110,"coordinates":289},[290,291],-114.08529,51.05011,{"lat":291,"lon":290},{"facility":102,"status":294,"city":295,"state":296,"zip":297,"country":286,"countryCode":287,"cosmosGeoPoint":298,"geoPoint":302,"contacts":58},"SUSPENDED","Vancouver","British Columbia","V5Z 4E6",{"type":110,"coordinates":299},[300,301],-123.11934,49.24966,{"lat":301,"lon":300},{"facility":102,"status":232,"city":304,"state":305,"zip":306,"country":286,"countryCode":287,"cosmosGeoPoint":307,"geoPoint":311,"contacts":58},"Halifax","Nova Scotia","B3H 2Y9",{"type":110,"coordinates":308},[309,310],-63.57688,44.64269,{"lat":310,"lon":309},{"facility":102,"status":103,"city":313,"state":314,"zip":315,"country":286,"countryCode":287,"cosmosGeoPoint":316,"geoPoint":320,"contacts":58},"Hamilton","Ontario","L8V 5C2",{"type":110,"coordinates":317},[318,319],-79.84963,43.25011,{"lat":319,"lon":318},{"facility":102,"status":232,"city":322,"state":314,"zip":323,"country":286,"countryCode":287,"cosmosGeoPoint":324,"geoPoint":328,"contacts":58},"Toronto","M5G 2L7",{"type":110,"coordinates":325},[326,327],-79.39864,43.70643,{"lat":327,"lon":326},{"facility":102,"status":294,"city":330,"state":331,"zip":332,"country":286,"countryCode":287,"cosmosGeoPoint":333,"geoPoint":337,"contacts":58},"Montreal","Quebec","H2L 4M1",{"type":110,"coordinates":334},[335,336],-73.58781,45.50884,{"lat":336,"lon":335},{"facility":102,"status":232,"city":330,"state":331,"zip":339,"country":286,"countryCode":287,"cosmosGeoPoint":340,"geoPoint":342,"contacts":58},"H3T 1E2",{"type":110,"coordinates":341},[335,336],{"lat":336,"lon":335},{"facility":102,"status":294,"city":344,"state":331,"zip":345,"country":286,"countryCode":287,"cosmosGeoPoint":346,"geoPoint":350,"contacts":58},"Québec","G1J 1Z4",{"type":110,"coordinates":347},[348,349],-71.21454,46.81228,{"lat":349,"lon":348},{"facility":102,"status":232,"city":352,"state":58,"zip":353,"country":354,"countryCode":58,"cosmosGeoPoint":355,"geoPoint":359,"contacts":58},"Adapazarı","54100","Turkey (Türkiye)",{"type":110,"coordinates":356},[357,358],30.40333,40.78056,{"lat":358,"lon":357},{"facility":102,"status":232,"city":361,"state":58,"zip":362,"country":354,"countryCode":58,"cosmosGeoPoint":363,"geoPoint":367,"contacts":58},"Antalya","07025",{"type":110,"coordinates":364},[365,366],30.69556,36.90812,{"lat":366,"lon":365},{"facility":102,"status":103,"city":369,"state":58,"zip":370,"country":354,"countryCode":58,"cosmosGeoPoint":371,"geoPoint":375,"contacts":58},"Istanbul","34098",{"type":110,"coordinates":372},[373,374],28.94966,41.01384,{"lat":374,"lon":373},{"facility":102,"status":232,"city":369,"state":58,"zip":377,"country":354,"countryCode":58,"cosmosGeoPoint":378,"geoPoint":380,"contacts":58},"34517",{"type":110,"coordinates":379},[373,374],{"lat":374,"lon":373},{"facility":102,"status":232,"city":369,"state":58,"zip":382,"country":354,"countryCode":58,"cosmosGeoPoint":383,"geoPoint":385,"contacts":58},"34899",{"type":110,"coordinates":384},[373,374],{"lat":374,"lon":373},{"facility":102,"status":232,"city":387,"state":58,"zip":388,"country":354,"countryCode":58,"cosmosGeoPoint":389,"geoPoint":393,"contacts":58},"Kocaeli","41380",{"type":110,"coordinates":390},[391,392],27.51145,39.62497,{"lat":392,"lon":391},{"facility":102,"status":232,"city":395,"state":58,"zip":396,"country":354,"countryCode":58,"cosmosGeoPoint":397,"geoPoint":401,"contacts":58},"Mezitli","33200",{"type":110,"coordinates":398},[399,400],34.52256,36.74541,{"lat":400,"lon":399},{"facility":102,"status":232,"city":403,"state":58,"zip":404,"country":405,"countryCode":406,"cosmosGeoPoint":407,"geoPoint":411,"contacts":58},"Edinburgh","EH4 2XU","United Kingdom","UK",{"type":110,"coordinates":408},[409,410],-3.19648,55.95206,{"lat":410,"lon":409},{"facility":102,"status":232,"city":413,"state":58,"zip":414,"country":405,"countryCode":406,"cosmosGeoPoint":58,"geoPoint":58,"contacts":58},"Hampshire","SO16 6YD",{"facility":102,"status":103,"city":416,"state":58,"zip":417,"country":405,"countryCode":406,"cosmosGeoPoint":418,"geoPoint":422,"contacts":58},"Leeds","LS9 7TF",{"type":110,"coordinates":419},[420,421],-1.54785,53.79648,{"lat":421,"lon":420},{"facility":102,"status":232,"city":424,"state":58,"zip":425,"country":405,"countryCode":406,"cosmosGeoPoint":426,"geoPoint":430,"contacts":58},"London","NW1 2BU",{"type":110,"coordinates":427},[428,429],-0.12574,51.50853,{"lat":429,"lon":428},{"facility":102,"status":232,"city":424,"state":58,"zip":432,"country":405,"countryCode":406,"cosmosGeoPoint":433,"geoPoint":435,"contacts":58},"SE5 9RS",{"type":110,"coordinates":434},[428,429],{"lat":429,"lon":428},{"facility":102,"status":232,"city":437,"state":58,"zip":438,"country":405,"countryCode":406,"cosmosGeoPoint":439,"geoPoint":443,"contacts":58},"Manchester","M20 4BX",{"type":110,"coordinates":440},[441,442],-2.23743,53.48095,{"lat":442,"lon":441},{"facility":102,"status":232,"city":445,"state":58,"zip":446,"country":405,"countryCode":406,"cosmosGeoPoint":447,"geoPoint":451,"contacts":58},"Nottingham","NG5 1PB",{"type":110,"coordinates":448},[449,450],-1.15047,52.9536,{"lat":450,"lon":449},{"facility":102,"status":232,"city":453,"state":58,"zip":454,"country":405,"countryCode":406,"cosmosGeoPoint":455,"geoPoint":459,"contacts":58},"Oxford","OX3 7LE",{"type":110,"coordinates":456},[457,458],-1.25596,51.75222,{"lat":458,"lon":457},{"facility":102,"status":232,"city":461,"state":58,"zip":462,"country":405,"countryCode":406,"cosmosGeoPoint":463,"geoPoint":467,"contacts":58},"Sutton","SM2 5PT",{"type":110,"coordinates":464},[465,466],-0.2,51.35,{"lat":466,"lon":465},{"type":469,"investigatorFullName":58,"investigatorTitle":58,"investigatorAffiliation":58,"oldNameTitle":58,"oldOrganization":58},"SPONSOR",[471],{"name":472,"class":6},"Parexel","100632089","surovatamig-as-consolidation-therapy-in-participants-with-chronic-lymphocytic-leukaemia-or-small-lymphocytic-lymphoma-with-unmutated-immunoglobulin-heavy-chain-variable-ighv-100632089",false,"NCT07509151","Surovatamig as Consolidation Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated Immunoglobulin Heavy Chain Variable (IGHV)","A Phase III, Randomised, Open-label, Multicentre, Study of Surovatamig as Consolidation Therapy Versus Observation After First-line Induction Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated IGHV (SOUNDTRACK-C1)","SOUNDTRACK-C1","Inclusion Criteria:\n\n* Documented diagnosis of CLL\u002FSLL with genomic features defined by unmutated IGHV.\n* Treatment received and response at the end of 1L (first-line) finite therapy.\n* Participants with SLL (except those in CR in Phase III part) must have measurable disease (nodal or extranodal) with at least one measurable target lesion.\n* ECOG performance status of 0 to 2.\n* Adequate haematologic, liver, renal and cardiac function.\n* Female participants: must be either women not of childbearing potential or must use a highly effective form of contraception.\n* Male participants who intend to be sexually active with females of childbearing potential must agree to use barrier contraception (eg, condoms).\n\nExclusion Criteria:\n\n* Suspected or confirmed transformation of CLL\u002FSLL to a more aggressive form of lymphoma (ie, Richter's transformation, prolymphocytic leukaemia, or DLBCL).\n* Evidence of active or history of Central Nervous System (CNS) involvement by CLL\u002FSLL.\n* History of or ongoing confirmed progressive multifocal leukoencephalopathy.\n* Participants who have any concurrent or history of malignancy.\n* Participants with:\n* Active or uncontrolled infection (including Epstein-Barr virus-EBV) requiring systemic therapy.\n* Participants with known history of Heamophagocytic lymphohistiocytosis (HLH).\n* Human Immunodeficiency Virus (HIV) infection, or participants with chronic or active infection with Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV).\n* Major cardiac abnormalities.\n* Prior CLL\u002FSLL-specific therapies.\n* Requires chronic immunosuppressive therapy for active autoimmune\u002Finflammatory condition or prior allogeneic stem cell or solid organ transplant.\n* Major surgical procedure.\n* Known hypersensitivity to surovatamig or any of the excipients of the product.","ALL","18 Years",{"count":484,"type":485},420,"ESTIMATED","INTERVENTIONAL",[488],"PHASE3","The purpose of this study is to evaluate the therapeutic benefit and safety of subcutaneous (SC) Surovatamig monotherapy as consolidation therapy in patients with Chronic Lymphocytic Leukaemia (CLL)\u002F Small Lymphocytic Lymphoma (SLL) with unmutated IGHV (uIGHV).",[491],"Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated IGHV",[493,494,495,496,497,498,499],"Leukaemia","Lymphoma","Monoclonal IgG4 antibody","Consolidation therapy","Therapeutic benefit","Induction therapy","B-cell malignancy","2026-10-05",{"date":502,"type":503},"2026-10-06","ACTUAL",{"date":505,"type":503},"2026-05-05",{"date":507,"type":485},"2032-04-05",{"name":5,"class":6},44]