[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100528256":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":51,"collaborators":54,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":19,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":19,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":19,"overallStatus":36,"whyStopped":19,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"The First Affiliated Hospital of Xiamen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ARCHOP","EXPERIMENTAL","Azacitidine in combination with R-CHOP",[13],"Drug: Azacitidine in combination with R-CHOP",[15],{"type":16,"name":11,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Specified dose on specified days:\n\nAzacitidine (A) 100mg subcutaneous d-1 to d-5 Rituximab (R) 375mg\u002Fm2 IV d0 Cyclophosphamide (C) 750mg\u002Fm2 IV d1 epirubicin (H) 75mg\u002Fm2 IV d1 or liposomal adriamycin (D) 25-30mg\u002Fm2 IV d1 Vincristine (O) 1.4mg\u002Fm2 (max 2mg) IV d1 Prednisone (P) 100mg orally d1-5",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Bing Xu","The First Aiffiliated hosptical of xiamen University","PRINCIPAL_INVESTIGATOR",[26,30],{"name":22,"role":27,"phone":28,"phoneExt":19,"email":29},"CONTACT","+8618750918842","xubingzhangjian@126.com",{"name":31,"role":27,"phone":32,"phoneExt":19,"email":33},"Zhifeng Li","+8613606901162","lzf_xm@163.com",[35],{"facility":22,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Xiamen","Fujian","361000","China","CN",{"type":43,"coordinates":44},"Point",[45,46],118.08187,24.47979,{"lat":46,"lon":45},[49,50],{"name":22,"role":27,"phone":28,"phoneExt":19,"email":29},{"name":31,"role":27,"phone":32,"phoneExt":19,"email":33},{"type":24,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Bing, Xu","Principal Investigator",[55,57,59,61],{"name":56,"class":6},"Jiangsu Provincial People's Hospital",{"name":58,"class":6},"Sun Yat-sen University",{"name":60,"class":6},"Chinese Academy of Medical Sciences",{"name":62,"class":6},"Shanxi Province Cancer Hospital","100528256","phase-2-aza-combined-with-rchop-in-p53-mutated-dlbcl-100528256",false,"NCT06158399","AZA Combined With RCHOP in P53-mutated DLBCL.","A Single-arm Clinical Study of Azacitidine in Combination With R-CHOP (ARCHOP) for the Treatment of TP53-mutated Previously Untreated Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n(1)18-70 years old; 2) New-onset TP53 mutant DLBCL; 3) ECOG 0-2; 4) LVEF \\>45%; 5) HBV-positive serology (occult carriers: anti-HBeAg +, HbsAg-, anti-HBsAg +\u002F-) only if HBV-DNA test is negative before enrollment; (6) Liver function: serum bilirubin ≤ 2.0 × ULN, serum ALT and AST ≤ 2.5 × ULN. Renal function: serum Cr ≤ 2.0 × ULN; (unless due to lymphoma); 7) Life expectancy ≥ 6 months; 8) Informed consent.\n\nExclusion Criteria:\n\n1. Primary and secondary central DLBCL;\n2. HIV-positive patients and or HCV active infection; (3) Clinically significant secondary cardiovascular disease;\n\n4\\) Combined hypoxemia severe chronic obstructive pulmonary disease; 5) Active bacterial, fungal, and, or viral infections not controlled by systemic therapy; 6) Apart from cured basal cell carcinoma of the skin or cervical cancer in situ or early prostate cancer not requiring systemic therapy or early breast cancer requiring only surgery alone. Within the last 3 years or concurrently with other malignant tumors; 7) Known hypersensitivity or allergic reaction to antibodies or proteins of the murine family","ALL","18 Years","70 Years",{"count":74,"type":75},52,"ESTIMATED","INTERVENTIONAL",[78],"PHASE2","To evaluate the efficacy and adverse effects of Azacitidine in combination with R-CHOP (ARCHOP) for the treatment of TP53-mutated previously untreated Diffuse large B-cell lymphoma",[81,82],"DLBCL - Diffuse Large B Cell Lymphoma","TP53","2025-02-18",{"date":85,"type":86},"2025-02-19","ACTUAL",{"date":88,"type":86},"2023-11-22",{"date":90,"type":75},"2026-05-31",{"name":5,"class":6},1]