[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100453316":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":35,"studyPopulation":28,"armGroups":36,"interventions":45,"overallOfficials":65,"centralContacts":69,"locations":75,"responsibleParty":91,"collaborators":28,"id":93,"slug":28,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":28,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":28,"enrollmentInfo":101,"targetDuration":28,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":77,"whyStopped":28,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"The First Affiliated Hospital of Soochow University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Overall Response Rate (ORR) at 6 cycles","The percentage of participants achieving a best overall response of confirmed Complete Response (CR) or Partial Response (PR) after treatment by Anti-PD-1 antibody plus Lenalidomide and Azacitidine.","From date of first dose until completion of 6 treatment cycles, assessed up to approximately 20 weeks.",[14,17,21,24],{"measure":15,"description":16,"timeFrame":12},"Complete Response Rate at 6 cycles","The percentage of patients who achieved complete response after treatment by Anti-PD-1 antibody plus Lenalidomide and Azacitidine",{"measure":18,"description":19,"timeFrame":20},"3-year progression-free survival (PFS) rate","3-year PFS rate is defined as the percentage of participants who are alive and free from disease progression at 3 years from the first dose of treatment. Participants who are alive and progression-free or lost to follow-up before 3 years will be censored at the date of last adequate tumor assessment.","up to 3 years",{"measure":22,"description":23,"timeFrame":20},"3-year Overall Survival(OS) Rate","3-year OS rate is defined as the percentage of participants who are alive at 3 years from the first Anti-PD-1 antibody plus Lenalidomide and Azacitidine. Participants who are alive or lost to follow-up before 3 years will be censored at the date of last known follow-up.",{"measure":25,"description":26,"timeFrame":27},"Adverse events profile","Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 will be tabulated","Measured from start of treatment until 28 days after last dose",null,{"allocation":30,"interventionModel":31,"interventionModelDescription":28,"primaryPurpose":32,"observationalModel":28,"timePerspective":28,"maskingInfo":33},"NA","SINGLE_GROUP","TREATMENT",{"masking":34,"maskingDescription":28,"whoMasked":28},"NONE","Peripheral T-cell lymphomas (PTCLs) are malignancies of immunologically mature T-cells that arise in peripheral lymphoid tissues. Compared with B-cell lymphoma, the treatment methods of PTCL are more limited, the first-line therapy is usually CHOP-like therapy, but the efficacy is poor, 5-year overall survival rate (OS) is only 30%-40%. Anti-PD-1 monoclonal antibody, Lenalidomide and Azacitidine can all have tumor-killing effects, and the three have complementary theoretical basis in the mechanism of action. This study will evaluate the efficacy and safety of Anti-PD-1 monoclonal antibody Combined Lenalidomide and Azacitidine in Relapsed\u002FRefractory Peripheral T-cell Lymphoma patients.",[37],{"label":38,"type":39,"description":40,"interventionNames":41},"Anti-PD-1 monoclonal antibody+Lenalidomide+Azacitidine","EXPERIMENTAL","Anti-PD-1 monoclonal antibody plus Lenalidomide, Azacitidine",[42,43,44],"Drug: Anti-PD-1 monoclonal antibody","Drug: Lenalidomide","Drug: Azacitidine",[46,53,59],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"DRUG","Anti-PD-1 monoclonal antibody","Anti-PD-1 monoclonal antibody, 200mg i.v d1 (\u002F21d)",[38],[52],"Anti-PD-1 antibody",{"type":47,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"Lenalidomide","Lenalidomide 25mg qd po d1-d10 (\u002F21d)",[38],[58],"Immunomodulator",{"type":47,"name":60,"description":61,"armGroupLabels":62,"otherNames":63},"Azacitidine","Azacitidine 75mg\u002Fm2 i.v d1-d7 (\u002F21d)",[38],[64],"5-Ladakamycin",[66],{"name":67,"affiliation":5,"role":68},"Depei Wu, M.D","STUDY_CHAIR",[70],{"name":71,"role":72,"phone":73,"phoneExt":28,"email":74},"Caixia Li, M.D","CONTACT","+86 512 67781856","licaixia@suda.edu.cn",[76],{"facility":5,"status":77,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"RECRUITING","Suzhou","Jiangsu","215000","China","CN",{"type":84,"coordinates":85},"Point",[86,87],120.59538,31.30408,{"lat":87,"lon":86},[90],{"name":71,"role":72,"phone":73,"phoneExt":28,"email":74},{"type":92,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100453316",false,"NCT05182957","Clinical Study on Anti-PD-1 Plus Lenalidomide and Azacitidine in Relapsed\u002FRefractory Peripheral T-cell Lymphoma","Clinical Study on the Efficacy and Safety of Anti-PD-1 Monoclonal Antibody Combined Lenalidomide and Azacitidine in Relapsed\u002FRefractory Peripheral T-cell Lymphoma","Inclusion Criteria:\n\n1. Pathological immunohistochemistry or flow cytometry confirmed that R\u002FR PTCL with measurable (diameter greater than 1.5cm) lesions meets any of the following conditions: 1\\> After 4 courses of standard first-line therapy or 2 courses of more than two-line therapy, the lesions were reduced by \\\u003C50%; 2\\> PTCL with disease progression after first-line or induction therapy; 3\\> After hematopoietic stem cell transplantation, new lesions appear or the size of previously affected lesions increased by more than 50%.\n2. Age ≥ 18 years.\n3. ECOG≤2分.\n4. The main organ functions need to meet the following conditions:Hemogram needs to meet HB ≥70\\*1012\u002FL，PLT≥50\\*109\u002FL，NE≥1\\*109\u002FL；LVEF≥50%;CR≤132umol\u002Fl or CCr≥60 ml\u002Fmin;ALT and AST≤2 times normal range；Lung function≤Level 1;dyspnea(CTCAE v5.0),and blood oxygen saturation without oxygen absorption\\> 91%.\n5. Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up one year period of the study.\n6. Estimated survival time ≥3 months.\n7. Voluntary signing of informed consent.\n\nExclusion Criteria:\n\n1. Accepted major surgery within 4 weeks before treatment.\n2. Prior malignancy (other than Relapsed\u002FRefractory Peripheral T-cell Lymphoma), except for cured malignant tumors with no active lesions for 3 years;Adequate treatment of inactive lesions in non-melanoma skin cancer,malignant tonsilloma or carcinoma in situ;\n3. Patients who have previously received failed allogeneic hematopoietic stem cell transplantation.\n4. Have stroke or intracranial hemorrhage within 3 months.\n5. Evidence of complications or medical conditions, including but not limited, that may interfere the conduct of the study or place the patient at serious risk:significant cardiovascular disease(class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification、myocardial infarction within 6 months of screening、uncontrolled or symptomatic arrhythmias) and\u002For significant lung disease.\n6. HIV infection and\u002For active hepatitis B or active hepatitis C.\n7. Uncontrolled systemic infection.\n8. Pregnant or breasting-feeding women.\n9. According to the researchers' judgment, any life-threatening disease, medical condition or organ system dysfunction which can endanger the patient's safety and Interfer with the absorption or metabolism of anti-PD-1 monoclonal antibody plus Lenalidomide and Azacitidine,may put the results of a study at unnecessary risk.","ALL","18 Years",{"count":102,"type":103},31,"ESTIMATED","INTERVENTIONAL",[106],"PHASE2","Aim of this study will evaluate the Efficacy and Safety of Anti-PD-1 monoclonal antibody Combined Lenalidomide and Azacitidine in Relapsed\u002FRefractory Peripheral T-cell Lymphoma Patients.",[109],"Relapsed\u002FRefractory Peripheral T-cell Lymphoma",[111],"Anti-PD-1 monoclonal antibody,Lenalidomide,Azacitidine","2026-04-26",{"date":114,"type":115},"2026-05-01","ACTUAL",{"date":117,"type":115},"2020-01-01",{"date":119,"type":103},"2026-06-15",{"name":5,"class":6},1]