[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"untreated-follicular-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:untreated-follicular-lymphoma":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":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100558321","phase-3-a-study-of-surovatamig-azd0486-plus-rituximab-in-previously-untreated-follicular-lymphoma-patients-100558321",false,"NCT06549595","A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients","A Phase III, Multicentre, Randomised, Open-label Study to Compare the Efficacy and Safety of AZD0486 Plus Rituximab Versus Chemotherapy Plus Rituximab in Previously Untreated Participants With Follicular Lymphoma (SOUNDTRACK-F1)","Inclusion Criteria:\n\n1. Participant must be at least 18 years of age, inclusive, at the time of signing the ICF.\n2. Histologically confirmed diagnosis of classic FL per WHO 2022 classification\n3. ECOG performance status of 0 to 2\n4. No prior systemic lymphoma-directed therapy\n5. Need for systemic treatment meeting at least 1 GELF criteria\n6. FDG-avid and measurable disease\n7. Stage II to IV and FLIPI 2-5 \\[Phase III only\\]\n8. Adequate liver, hematological, renal and cardiac function.\n\nThe above is a summary, other inclusion criteria details may apply\n\nExclusion Criteria:\n\n1. Follicular large B-cell lymphoma (WHO 2022 classification), formerly Follicular lymphoma Grade 3B (WHO 2016 classification) or suspicion for histologic transformation to high-grade\u002Faggressive lymphoma\n2. Contra-indication to BR, RCVP, and R-CHOP\n3. Participants with or history of CNS lymphoma\n4. History of a clinically relevant CNS medical condition or pathology that required treatment in the preceding year, is currently symptomatic or that which the treating investigator considers to have the potential to interfere with the evaluation of safety\n5. Presence of \\>5000 circulating lymphoma cells\n6. Active or uncontrolled infection (including EBV) requiring systemic therapy and which places participant at unacceptable risk if he\u002Fshe were to participate in the study. If a participant has a history of COVID-19 within 1 month of C1D1 or contracts COVID while on study treatment, participant must have 2 consecutive negative tests (PCR testing is preferable) performed at least 48 hours apart prior to resuming dosing. All symptoms related to COVID-19 infection should have fully resolved before initiating or resuming treatment\n7. Known history of hemophagocytic lymphohistiocytosis\u002Fmacrophage activation syndrome (HLH\u002FMAS)\n\nThe above is a summary, other exclusion criteria details may apply","ALL","18 Years","130 Years",{"count":20,"type":21},1018,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a global, randomised, Phase III, multicentre, open-label study evaluating the efficacy, safety and the degree of added benefit of the Surovatamig (AZD0486) plus rituximab combination compared to Investigator's choice of 3 standard immunochemotherapy regimen, conducted in participants with untreated FL.",[27],"Untreated Follicular Lymphoma",[29],"Follicular Lymphoma","RECRUITING","2026-08-18",{"date":33,"type":34},"2026-08-19","ACTUAL",{"date":36,"type":34},"2024-08-07",{"date":38,"type":21},"2031-11-26",{"name":40,"class":41},"AstraZeneca","INDUSTRY",228]