[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567709":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":19,"centralContacts":23,"locations":31,"responsibleParty":45,"collaborators":48,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":18,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":18,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":79,"whyStopped":18,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8],{"label":9,"type":10,"description":9,"interventionNames":11},"Pralatrexate combined with Chidamide bridging allo-HSCT for Relapse\u002FRefractory PTCL patients","EXPERIMENTAL",[12],"Other: Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation",[14],{"type":6,"name":15,"description":16,"armGroupLabels":17,"otherNames":18},"Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation","Drug: Pralatrexate, Chidamide\n\n1. Pralatrexate: 30 mg\u002Fm2 intravenously (IV) administered weekly in 6-week cycles. Chidamide: 20mg, twice a week in 3-week cycles (2 weeks on treatment, 1 week off treatment)\n2. After the 6-week therapy, the patients should receive PET\u002FCT evaluation.\n3. Patients would receive allo-HSCT if they could achieve at least PR after the first cycle of therapy. For the patients could not achieve a least PR after the first cycle of therapy, they should receive a second cycle of pralatrexate combined with chidamide. The interval between two cycles of pralatrexate combined with chidamide should be at least 1 week.\n4. After the second cycle of 6-week therapy, the patients should receive PET\u002FCT evaluation. Patients would receive allo-HSCT if they could achieve at least SD after the second cycle of therapy. For the patients could not achieve a least SD after the second cycle of therapy, they should receive other salvage therapies.",[9],null,[20],{"name":21,"affiliation":5,"role":22},"Xiaodong Mo","PRINCIPAL_INVESTIGATOR",[24,29],{"name":25,"role":26,"phone":27,"phoneExt":18,"email":28},"Xiaodong Mo, MD","CONTACT","8610-8832-6001","mxd453@163.com",{"name":25,"role":26,"phone":30,"phoneExt":18,"email":28},"8610-8832-4577",[32],{"facility":33,"status":18,"city":34,"state":18,"zip":18,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Peking University, Institute of Hematolgoy, Beijing,","Beijing","China","CN",{"type":38,"coordinates":39},"Point",[40,41],116.39723,39.9075,{"lat":41,"lon":40},[44],{"name":21,"role":26,"phone":18,"phoneExt":18,"email":18},{"type":22,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Xiao-Jun Huang","Director",[49,51,53],{"name":50,"class":6},"Ruijin Hospital",{"name":52,"class":6},"Wuhan TongJi Hospital",{"name":54,"class":6},"West China Hospital","100567709","pralatrexate-combined-with-chidamide-bridging-allogeneic-hsct-for-refractoryrelapsed-peripheral-t-cell-lymphoma-100567709",false,"NCT06671717","Pralatrexate Combined With Chidamide Bridging Allogeneic HSCT for Refractory\u002FRelapsed Peripheral T-cell Lymphoma","Pralatrexate Combined With Chidamide Bridging Allogeneic Hematopoietic Stem Cell Transplantation for Refractory\u002FRelapsed Peripheral T-cell Lymphoma","Inclusion Criteria:\n\n* Patients fully understand the study, voluntarily participate in and sign on the informed consent;\n* Diagnosed by histopathology Peripheral T-cell lymphoma;\n* ECOG PS score 0 or 1;\n* Relapsed or Refractory Peripheral T Cell Lymphoma；\n* According to the 2014 version of the Lugano criteria for lymphoma, there must be at least one CT\u002FMRI measurable lesion (measurable lymph node diameter\\>1.5cm; measurable extranodal lesion diameter\\>1.0cm)；\n* Provided a written pathological\u002Fhistological diagnosis report during the screening period and agreed to provide tumor tissue sections or tumor\u002Flymph node tissue specimens for testing at the central laboratory;\n* Expected survival at least 12 weeks；\n* Agreed to receive treatment with Pralatrexate\n\nExclusion Criteria:\n\n* NK\u002FT-cell lymphoma;\n* Achieving CR or PR after induction chemotherapies without relapse;\n* Dysfunction of vital organs;\n* Serious history of autoimmune diseases and immunodeficiency, including: positive for human immunodeficiency virus (HIV) antibodies; Or other acquired or congenital immunodeficiency diseases; Or have a history of organ transplantation;\n* Unwilling to accept allogeneic hematopoietic stem cell transplantation;\n* Undergoing other clinical studies within a month;\n* Without donor for transplantation;\n* Allergies to similar drugs and excipients of the research drug","ALL","18 Years","65 Years",{"count":66,"type":67},25,"ESTIMATED","INTERVENTIONAL",[70],"NA","This is a multicenter, prospective study of Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation for Refractory\u002FRelapsed Peripheral T-cell Lymphoma",[73,74],"Relapsed Peripheral T-Cell Lymphoma","Refractory Peripheral T-Cell Lymphoma",[76,77,78],"Allogeneic hematopoietic stem cell transplantation","Pralatrexate","Remission status before transplantation","NOT_YET_RECRUITING","2024-11-04",{"date":82,"type":83},"2024-11-06","ACTUAL",{"date":85,"type":67},"2024-12",{"date":87,"type":67},"2027-07",{"name":5,"class":6},1]