[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574802":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":47,"collaborators":20,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":20,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":20,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"First Affiliated Hospital of Ningbo University","NETWORK",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CHiR","EXPERIMENTAL","The combined regimen of chidamide, zanubrutinib, and lenalidomide (CHiR) is employed to treat elderly patients with double-expressor lymphoma. This study aims to explore the efficacy and safety of this regimen in newly diagnosed elderly patients with diffuse large B-cell lymphoma (DLBCL) who are intolerant to chemotherapy.",[13],"Drug: CHiR-DEL",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","CHiR-DEL","Using the combined regimen of CHiR (chidamide, zanubrutinib, and lenalidomide) to treat newly diagnosed elderly patients with MYC- and BCL2-expressing positive diffuse large B-cell lymphoma (DLBCL) who are intolerant to chemotherapy.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Lixia Chief Physician","CONTACT","15968985233","slx800408@163.com",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"The First Affiliated Hospital of Ningbo University","RECRUITING","Ningbo","Zhejiang","3150101","China","CN",{"type":37,"coordinates":38},"Point",[39,40],121.54945,29.87819,{"lat":40,"lon":39},[43],{"name":44,"role":24,"phone":20,"phoneExt":45,"email":46},"Shaoying Chen","0574-87085233","1987951774@qq.com",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Lixia Sheng","Chief Physician","100574802","phase-2-chir-therapy-for-elderly-dlbcl-intolerant-to-chemo-100574802",false,"NCT06764017","CHiR Therapy for Elderly DLBCL Intolerant to Chemo","A Single-arm, Multicenter, Prospective Clinical Study of CHiR (chidamide, Zanubrutinib, and Lenalidomide) for Newly Diagnosed MYC- and BCL2-positive Diffuse Large B-cell Lymphoma (DLBCL) in Elderly Patients Intolerant to Chemotherapy.","Inclusion Criteria：\n\n1. Age ≥ 70 years;\n2. ECOG score of 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. Immunohistochemically confirmed positive expression of MYC and BCL2 (MYC ≥ 40%, BCL2 ≥ 50% by immunohistochemistry);\n6. Previously untreated patients;\n7. Cardiac, hepatic, and renal function: creatinine \\\u003C 2 times the upper limit of normal (ULN); ALT (alanine aminotransferase)\u002FAST (aspartate aminotransferase) \\\u003C 2.5 ULN; total bilirubin \\\u003C 2 ULN;\n8. At least one measurable lesion;\n9. Unable to tolerate standard CHOP regimen chemotherapy or unwilling to receive chemotherapy;\n10. Adequate understanding and voluntary signing of the informed consent form. Exclusion Criteria：\n\n1.Patients with central nervous system involvement at the time of onset; 2.Known human immunodeficiency virus (HIV) infection; 3.Pregnant or lactating women; 4.Other tumors requiring treatment; 5.Uncontrollable active infection; 6.Active hepatitis with HBV-DNA copy number not controlled within 2\\*1000\u002FmL despite antiviral treatment; 7.Inability to understand, comply with the study protocol, or sign the informed consent form.","ALL","70 Years","100 Years",{"count":62,"type":63},30,"ESTIMATED","INTERVENTIONAL",[66],"PHASE2","The objective of exploring the application of CHiR is to evaluate its therapeutic efficacy and safety in newly diagnosed elderly patients with diffuse large B-cell lymphoma (DLBCL) aged 70 and above, and to investigate the genetic subtypes that may benefit from CHiR. The primary endpoint is the complete remission rate (CRR) at the end of 8 cycles.",[69],"Diffuse Large B-Cell Lymphoma",[71,72,73,74,75,76],"diffuse large B-cell lymphoma","MYC- and BCL2-positive","chidamide","zanubrutinib","lenalidomide","elderly patients","2025-03-16",{"date":79,"type":80},"2025-03-19","ACTUAL",{"date":82,"type":80},"2025-02-01",{"date":84,"type":63},"2027-08-01",{"name":5,"class":6},1]