[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsedrefractory-marginal-zone-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsedrefractory-marginal-zone-lymphoma":26},{"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":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100522398","phase-3-efficacy-and-safety-of-orelabrutinib-combined-with-rituximab-versus-lenalidomide-combined-with-rituximab-in-patients-with-relapsedrefractory-marginal-zone-lymphoma-100522398",false,"NCT06082102","Efficacy and Safety of Orelabrutinib Combined With Rituximab Versus Lenalidomide Combined With Rituximab in Patients With Relapsed\u002FRefractory Marginal Zone Lymphoma","A Randomized, Controlled, Open-label, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Orelabrutinib Plus Rituximab Versus Lenalidomide Plus Rituximab in Relapsed\u002FRefractory Marginal Zone Lymphoma","Inclusion Criteria:\n\n1. Age ≥ 18 years , either sex.\n2. Histopathologically confirmed B-cell non-Hodgkin lymphoma MZL (splenic, nodal, or extra-nodal).\n3. Prior systemic therapy including at least one anti-CD20 monoclonal antibody-containing regimen is required, with the following specifications:\n\n   For combination therapies: Minimum of 2 completed treatment cycles For anti-CD20 monotherapy: Minimum of 4 administered doses Progression during treatment waives cycle\u002Fdose requirements\n4. Relapsed or refractory disease.\n5. At least 1 measurable lesion confirmed through enhanced computed tomography (CT) or enhanced magnetic resonance imaging (MRI).\n6. ECOG performance status (PS) score of 0-2.\n\nExclusion Criteria:\n\n1. Administration of the specified anti-tumor therapies within 2 weeks prior to the first dose of the study treatment.\n2. Administration of any other investigational product within 4 weeks prior to the first dose of the study treatment, or concurrent participation in another clinical trial.(Excluding patients who have discontinued treatment and are in long-term follow-up).\n3. Prior treatment with any types of BTK inhibitor.\n4. Patients refractory to lenalidomide plus rituximab (R2 regimen). Refractoriness is defined as either: Failure to achieve at least partial response (PR) after completing an adequate R2 treatment course (≥2 cycles at standard doses), OR Disease progression during R2 therapy or within 6 months after the last dose.\n5. Central nervous system (CNS) lymphoma, and lymphoma with CNS or meningeal involvements.","ALL","18 Years",{"count":19,"type":20},324,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","Efficacy and Safety of Orelabrutinib Combined with Rituximab versus Lenalidomide Combined with Rituximab in Patients with Relapsed\u002FRefractory Marginal Zone Lymphoma",[26],"Relapsed\u002FRefractory Marginal Zone Lymphoma","RECRUITING","2025-09-12",{"date":30,"type":31},"2025-09-15","ACTUAL",{"date":33,"type":31},"2023-12-19",{"date":35,"type":20},"2030-02-25",{"name":37,"class":38},"Beijing InnoCare Pharma Tech Co., Ltd.","INDUSTRY",19]