[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554759":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":27,"studyPopulation":20,"armGroups":28,"interventions":39,"overallOfficials":47,"centralContacts":51,"locations":57,"responsibleParty":76,"collaborators":20,"id":79,"slug":20,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":20,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":20,"enrollmentInfo":87,"targetDuration":20,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":20,"overallStatus":60,"whyStopped":20,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Navy General Hospital, Beijing","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"EFS","EFS was defined as the time from treatment initiation to progression, relapse, new treatment, or death by any cause, whichever occurred first.","2 years",[14,17],{"measure":15,"description":16,"timeFrame":12},"PFS","PFS was defined as the time from study entry until disease progression or death by any cause",{"measure":18,"description":19,"timeFrame":12},"OS","OS was defined as the time from treatment initiation to death by any cause.",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":24,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":26,"maskingDescription":20,"whoMasked":20},"NONE","The investigators will evaluate safety and efficacy of zanubrutinib and lenalidomide as maintenance therapy in patients with diffuse large B-cell lymphoma post complete remission and have completed planed courses of chemotherapy . Event-free survival (EFS), progression-free survival (PFS), overall survival (OS), adverse events (AEs) will be assessed.",[29,35],{"label":30,"type":31,"description":32,"interventionNames":33},"Maintenance Therapy","EXPERIMENTAL","Patients were treated by Zanubrutinib plus Lenalidomide as Maintenance Therapy",[34],"Drug: Zanubrutinib plus Lenalidomide as Maintenance Therapy",{"label":36,"type":37,"description":38,"interventionNames":20},"No maintenance Therapy","NO_INTERVENTION","Patients received no maintenance Therapy",[40],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"DRUG","Zanubrutinib plus Lenalidomide as Maintenance Therapy","Patients were treated by Zanubrutinib(160mg po bid d1-28) plus Lenalidomide(25mg po qd d1-14) as maintenance therapy until 2 years post chemotherpay",[30],[46],"Zanubrutinib plus Lenalidomide",[48],{"name":49,"affiliation":5,"role":50},"qlr2007@126.com Qian, PhD","PRINCIPAL_INVESTIGATOR",[52],{"name":53,"role":54,"phone":55,"phoneExt":20,"email":56},"Liren Qian, PhD","CONTACT","+861066947192","qlr2007@126.com",[58],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Navy General Hospital","RECRUITING","Beijing","Beijing Municipality","100048","China","CN",{"type":67,"coordinates":68},"Point",[69,70],116.39723,39.9075,{"lat":70,"lon":69},[73],{"name":74,"role":54,"phone":75,"phoneExt":20,"email":56},"Liren Qian, M.D.","+861066947194",{"type":50,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Liren Qian","Vice Director","100554759",false,"NCT06503263","Zanubrutinib and Lenalidomide as Maintenance Therapy in DLBCL","Zanubrutinib and Lenalidomide as Maintenance Therapy in Patients With Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n* Pathologically confirmed Diffuse Large B Cell Lymphoma according World Health Organization (WHO) classification;\n* Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).\n* Patient must understand and voluntarily sign an ICF prior to any study-specific assessments\u002Fprocedures being conducted;\n* Patient is willing and able to adhere to the study visit schedule and other protocol requirements;\n* Patient has recieved complete remission and has completed planed courses of chemotherapy\n* Meet the following lab criteria: Absolute Neutrophil Count (ANC) ≥ 1,5 x 10\\^9\u002FL (≥ 1 x 10\\^9\u002FL if bone marrow (BM) involvement by lymphoma)；Platelet ≥ 75 x 10\\^9\u002FL (≥ 50 x 10\\^9\u002FL if BM involvement by lymphoma)； Hemoglobin ≥ 8 g\u002FdL. Anticipated life expectancy at least 3 months\n\nExclusion Criteria:\n\n* Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment;\n* Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy;\n* Pregnant or lactating women","ALL","14 Years",{"count":88,"type":89},240,"ESTIMATED","INTERVENTIONAL",[92],"PHASE2","The goal of this phase 2 trial is to test the safety and efficacy of zanubrutinib and lenalidomide as maintenance therapy in patients with DLBCL.",[95],"Diffuse Large B-cell Lymphoma","2024-09-05",{"date":98,"type":99},"2024-09-19","ACTUAL",{"date":101,"type":99},"2024-08-30",{"date":103,"type":89},"2030-12-30",{"name":5,"class":6},1]