[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575988":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":28,"locations":34,"responsibleParty":51,"collaborators":10,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":10,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":10,"enrollmentInfo":64,"targetDuration":10,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1: DLBCL patients diagnosed unfit\u002F Unfit.",null,"A person who is unfit\u002F unfit is defined as being 80 years or older, or younger than 80 years old but has comorbidities and cannot tolerate a standard dose of chemotherapy as determined by the investigator.",[13],"Drug: Low intensity treatment options",{"label":15,"type":10,"description":15,"interventionNames":16},"Cohort 2: Patients diagnosed with DLBCL who cannot be classified as unfit\u002F Unfit.",[17],"Drug: Conventional immunochemotherapy regimen",[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DRUG","Low intensity treatment options","Reference options for a combined regimen include C-R2, C-R-mini-CHOP, etc.\n\nSubjects whose efficacy is assessed as CR after the end of induction therapy will enter consolidation therapy. Tucidinostat maintenance therapy or autologous hematopoietic stem cell transplantation may be an option. Tucidinostat maintenance therapy will be performed every 3 weeks. .Single-drug maintenance is recommended to last 24 weeks",[9],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"Conventional immunochemotherapy regimen","Reference options for a combined regimen include CR-CHOP, C-Pola-R-CHP, etc.\n\nSubjects whose efficacy is assessed as CR after the end of induction therapy will enter consolidation therapy. Tucidinostat maintenance therapy or autologous hematopoietic stem cell transplantation may be an option. Tucidinostat maintenance therapy will be performed every 3 weeks. Single-drug maintenance is recommended to last 24 weeks",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Pengpeng Xu, professor","CONTACT","13564015001","pengpeng_xu@126.com",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":10,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"No. 197 Ruijin 2nd Road, Huangpu District, Shanghai","RECRUITING","Shanghai","Shanghai Municipality","China","CN",{"type":43,"coordinates":44},"Point",[45,46],121.45806,31.22222,{"lat":46,"lon":45},[49],{"name":50,"role":31,"phone":32,"phoneExt":10,"email":33},"Pengpeng Xu",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Zhao Weili","Principal Investigator","100575988","a-multicenter-prospective-real-world-study-of-a-regimen-containing-tucidinostat-for-primary-treatment-of-dlbcl-100575988",false,"NCT06779435","A Multicenter, Prospective, Real-world Study of a Regimen Containing Tucidinostat for Primary Treatment of DLBCL","A Multicenter, Prospective, Real-world Study of a Regimen Containing Tucidinostat for Primary Treatment of Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n* 1\\. Age ≥18 years old, male or female;\n* 2\\. No previous treatment for DLBCL, including chemotherapy, targeted therapy and immunotherapy;\n* 3\\. DEL \\[Diffuse large B-cell lymphoma with double expression of MYC and BCL2 (immunohistochemical MYC≥40%, BCL2≥50%)\\] was confirmed by pathology; Or non-double expression but at least one of the following:;\n\n  1. TP53 or other epigenetic gene mutations (as in: ACTB, BCL6, BCOR, CREBBP, EP300, EZH2, HIST1H1C, HIST1H1E, HIST1H2BK, HIST2H2AB, IRF4, KMT2A, KMT2C, KMT2D, MYC, MYD88, NSD2, RAG1, SETD1B SF3B1, SIN3A, TBL1XR1, TET2, TOX, TP53, TRIP12, TRRAP, UBE2A)\n  2. MYC and BCL2 double hit\n* 4\\. Plan to receive or are receiving a treatment regimen containing tucidinostat (if it is permitted to start using tucidinostat after obtaining specific test results due to pending genetic sequencing results);\n* 5\\. Voluntarily sign informed consent.\n\nExclusion Criteria:\n\n* 1\\. Patients currently enrolled or planning to participate in any interventional clinical trial;\n* 2\\. The expected survival time is less than 6 months;\n* 3\\. There are any other reasons that the investigators believe are not suitable for patients to participate in this study.","ALL","18 Years",{"count":65,"type":66},400,"ESTIMATED","OBSERVATIONAL","This is a prospective, observational, multicenter, cohort study with 400 newly treated DLBCL patients. To evaluate the clinical efficacy and safety of tucidinostat in the real-world treatment of primary diffuse large B-cell lymphoma",[70],"DLBCL",[72,70],"Tucidinostat","2025-02-17",{"date":75,"type":76},"2025-02-19","ACTUAL",{"date":78,"type":76},"2025-01-01",{"date":80,"type":66},"2028-06-30",{"name":5,"class":6},1]