[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-lymphocytic-leukaemia-or-small-lymphocytic-lymphoma-with-unmutated-ighv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-lymphocytic-leukaemia-or-small-lymphocytic-lymphoma-with-unmutated-ighv":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"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":20,"type":21},420,"ESTIMATED","INTERVENTIONAL",[24],"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).",[27],"Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated IGHV",[29,30,31,32,33,34,35],"Leukaemia","Lymphoma","Monoclonal IgG4 antibody","Consolidation therapy","Therapeutic benefit","Induction therapy","B-cell malignancy","RECRUITING","2026-10-05",{"date":39,"type":40},"2026-10-06","ACTUAL",{"date":42,"type":40},"2026-05-05",{"date":44,"type":21},"2032-04-05",{"name":46,"class":47},"AstraZeneca","INDUSTRY",44]