[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100453316":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":36,"centralContacts":40,"locations":47,"responsibleParty":63,"collaborators":45,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":45,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":45,"enrollmentInfo":74,"targetDuration":45,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":49,"whyStopped":45,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"The First Affiliated Hospital of Soochow University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Anti-PD-1 monoclonal antibody+Lenalidomide+Azacitidine","EXPERIMENTAL","Anti-PD-1 monoclonal antibody plus Lenalidomide, Azacitidine",[13,14,15],"Drug: Anti-PD-1 monoclonal antibody","Drug: Lenalidomide","Drug: Azacitidine",[17,24,30],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Anti-PD-1 monoclonal antibody","Anti-PD-1 monoclonal antibody, 200mg i.v d1 (\u002F21d)",[9],[23],"Anti-PD-1 antibody",{"type":18,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"Lenalidomide","Lenalidomide 25mg qd po d1-d10 (\u002F21d)",[9],[29],"Immunomodulator",{"type":18,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Azacitidine","Azacitidine 75mg\u002Fm2 i.v d1-d7 (\u002F21d)",[9],[35],"5-Ladakamycin",[37],{"name":38,"affiliation":5,"role":39},"Depei Wu, M.D","STUDY_CHAIR",[41],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Caixia Li, M.D","CONTACT","+86 512 67781856",null,"licaixia@suda.edu.cn",[48],{"facility":5,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Suzhou","Jiangsu","215000","China","CN",{"type":56,"coordinates":57},"Point",[58,59],120.59538,31.30408,{"lat":59,"lon":58},[62],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},{"type":64,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR","100453316","phase-2-clinical-study-on-anti-pd-1-plus-lenalidomide-and-azacitidine-in-relapsedrefractory-peripheral-t-cell-lymphoma-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":75,"type":76},31,"ESTIMATED","INTERVENTIONAL",[79],"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.",[82],"Relapsed\u002FRefractory Peripheral T-cell Lymphoma",[84],"Anti-PD-1 monoclonal antibody,Lenalidomide,Azacitidine","2026-04-26",{"date":87,"type":88},"2026-05-01","ACTUAL",{"date":90,"type":88},"2020-01-01",{"date":92,"type":76},"2026-06-15",{"name":5,"class":6},1]