[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574342":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":23,"locations":24,"responsibleParty":45,"collaborators":23,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":23,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":27,"whyStopped":23,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"First Affiliated Hospital of Ningbo University","NETWORK",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with newly diagnosed, CD20+, elderly, chemotherapy-intolerant DLBCL","EXPERIMENTAL","All patients will receive one cycle of HiR (Zebtorizumab, Lenalidomide) induction therapy. On the first day of enrollment, tissue NGS and peripheral blood ctDNA will be submitted for testing. For the remaining six cycles, the added drug (X) will be determined based on the NGS molecular typing results. Please refer to the grouping scheme for details.\n\nHiR+X Dosing Scheme:\n\nHi: Zebtorizumab 375mg\u002Fm², d1; R: Lenalidomide 10-25mg d1-10 (maximum tolerated dose)\n\nX:\n\nFor MCD\u002FBN2\u002FTP53: Ocalivumab 150mg qd For EZB: Chidamide 30mg biw\n\nFor N1-like and nonspecific types:\n\nIf EBV-positive: PD-1 monoclonal antibody 200mg Q3W",[13],"Drug: Drug therapy",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"DRUG","Drug therapy",[9],[20,21,22],"Ocalivumab","Chidamide","PD-1 monoclonal antibody",null,[25],{"facility":26,"status":27,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"The First Affiliated Hospital of Ningbo University","RECRUITING","Ningbo","Zhejiang","3150101","China","CN",{"type":34,"coordinates":35},"Point",[36,37],121.54945,29.87819,{"lat":37,"lon":36},[40],{"name":41,"role":42,"phone":43,"phoneExt":23,"email":44},"Sheng","CONTACT","0574-87089203","fyyshenglixia@nbu.edu.cn",{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Lixia Sheng","Chief Physician","100574342","phase-2-clinical-study-of-hirx-therapy-for-newly-diagnosed-elderly-patients-with-dlbcl-intolerant-to-chemotherapy-100574342",false,"NCT06758037","Clinical Study of HiR+X Therapy for Newly Diagnosed Elderly Patients With DLBCL Intolerant to Chemotherapy","A Single-arm, Multicenter Phase II Clinical Study of HiR+X Therapy for Newly Diagnosed Diffuse Large B-cell Lymphoma (DLBCL) in Elderly Patients Intolerant to Chemotherapy, Guided by Molecular Subtyping and Clinical Characteristics.","HiR+X","Inclusion Criteria:\n\n1. Age ≥ 70 years;\n2. ECOG score 0-3;\n3. Rated as \"unfit\" or \"frail\" on the simplified geriatric assessment (sGA);\n4. Histologically confirmed CD20-positive diffuse large B-cell lymphoma \\[diagnostic criteria according to WHO 2016\\], excluding transformed type 2 DLBCL;\n5. Previously untreated, newly diagnosed patients;\n6. Cardiac, hepatic, and renal function: creatinine \\\u003C 2 times the upper limit of normal (ULN); ALT (alanine aminotransferase) \u002F AST (aspartate aminotransferase) \\\u003C 2.5 x ULN; total bilirubin \\\u003C 2 x ULN;\n7. At least one measurable lesion;\n8. Intolerance to standard CHOP chemotherapy regimen or unwillingness to receive chemotherapy;\n9. Sufficient understanding and voluntary signing of the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with central nervous system involvement at the onset of the disease;\n2. Known human immunodeficiency virus (HIV) infection;\n3. Pregnant or lactating women;\n4. Other tumors requiring treatment;\n5. Uncontrolled active infection;\n6. Active hepatitis with HBV-DNA copy number unable to be controlled within 2000\u002FmL despite antiviral treatment;\n7. Individuals who cannot understand, comply with the study protocol, or sign the informed consent form.","ALL","70 Years","100 Years",{"count":61,"type":62},50,"ESTIMATED","INTERVENTIONAL",[65],"PHASE2","To explore the application of HiR (Zebtorizumab, Lenalidomide) + X (targeted drug) guided by NGS molecular typing, the aim is to assess the therapeutic efficacy and safety in newly diagnosed unfit or frail elderly patients with DLBCL aged ≥70 years, and to investigate the genetic subtypes that may benefit from HiR-X.",[68,69],"DLBCL","Diffuse Large B-Cell Lymphoma",[68,71,72,73,74],"genetic subtypes","Zebtorizumab","Lenalidomide","unfit","2025-03-16",{"date":77,"type":78},"2025-03-18","ACTUAL",{"date":80,"type":78},"2025-01-15",{"date":82,"type":62},"2027-06-30",{"name":5,"class":6},1]