[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647374":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":36,"centralContacts":53,"locations":64,"responsibleParty":83,"collaborators":36,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":36,"studyType":101,"phases":102,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":113,"whyStopped":36,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8,15,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Subgroup 1","EXPERIMENTAL","TET2\u002FRHOA co-mutated genetic subtype",[13,14],"Drug: Azacitidine plus Selinexor with CHOP","Drug: CHOP",{"label":16,"type":10,"description":17,"interventionNames":18},"Subgroup 2","TP53-mutated genetic subtype",[19,14],"Drug: Decitabine plus Selinexor with CHOP",{"label":21,"type":10,"description":22,"interventionNames":23},"Subgroup 3","Core epigenetic genes-mutated genetic subtype",[24,14],"Drug: Zeprumetostat plus chidamide with CHOP",{"label":26,"type":10,"description":27,"interventionNames":28},"Subgroup 4","Other genetic subtype",[29,14],"Drug: Azacitidine plus Golidocitinib with CHOP",[31,37,41,45,49],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Azacitidine plus Selinexor with CHOP","Patients in this arm will receive cyclophosphamide 750 mg\u002Fm² IV, doxorubicin 50 mg\u002Fm² IV, and vincristine 1.4 mg\u002Fm² IV (maximum 2 mg) on day 1, and prednisone 100 mg\u002Fday PO on days 1-5 for the first cycle. If tumor NGS indicates TP53-mutated genetic subtype, then 1:1 randomized to experimental (CHOPX2) or standard CHOP regimen for 5 cycles of every 28-day cycle. Patients in CHOPX2 group will receive azacitidine d-5 to d-1 and Selinexor 40mg qw combined with standard CHOP.",[9],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Decitabine plus Selinexor with CHOP","Patients in this arm will receive cyclophosphamide 750 mg\u002Fm² IV, doxorubicin 50 mg\u002Fm² IV, and vincristine 1.4 mg\u002Fm² IV (maximum 2 mg) on day 1, and prednisone 100 mg\u002Fday PO on days 1-5 for the first cycle. If tumor NGS indicates TP53-mutated genetic subtype, then 1:1 randomized to experimental (CHOPX2) or standard CHOP regimen for 5 cycles of every 28-day cycle. Patients in CHOPX2 group will receive Decitabine RP2D (confrimed by phase I) and Selinexor 40mg qw combined with standard CHOP.",[16],{"type":32,"name":42,"description":43,"armGroupLabels":44,"otherNames":36},"Zeprumetostat plus chidamide with CHOP","Patients in this arm will receive cyclophosphamide 750 mg\u002Fm² IV, doxorubicin 50 mg\u002Fm² IV, and vincristine 1.4 mg\u002Fm² IV (maximum 2 mg) on day 1, and prednisone 100 mg\u002Fday PO on days 1-5 for the first cycle. If tumor NGS indicates core epigenetic genes-mutated genetic subtype, then 1:1 randomized to experimental (CHOPX2) or standard CHOP regimen for 5 cycles of every 28-day cycle. Patients in CHOPX2 group will receive Zeprumetostat RP2D (confrimed by phase I) and chidamide 20mg biw combined with standard CHOP.",[21],{"type":32,"name":46,"description":47,"armGroupLabels":48,"otherNames":36},"Azacitidine plus Golidocitinib with CHOP","Patients in this arm will receive cyclophosphamide 750 mg\u002Fm² IV, doxorubicin 50 mg\u002Fm² IV, and vincristine 1.4 mg\u002Fm² IV (maximum 2 mg) on day 1, and prednisone 100 mg\u002Fday PO on days 1-5 for the first cycle. If tumor NGS indicates other genetic subtype, then 1:1 randomized to experimental (CHOPX2) or standard CHOP regimen for 5 cycles of every 28-day cycle. Patients in CHOPX2 group will receive Azacitidine ih d-5-d-1 and Golidocitinib RP2D (confirmed by Phase I) combined with standard CHOP.",[26],{"type":32,"name":50,"description":51,"armGroupLabels":52,"otherNames":36},"CHOP","Patients in this arm will receive cyclophosphamide 750 mg\u002Fm² IV, doxorubicin 50 mg\u002Fm² IV, and vincristine 1.4 mg\u002Fm² IV (maximum 2 mg) on day 1, and prednisone 100 mg\u002Fday PO on days 1-5 for cycle 1 to cycle 6.",[9,16,21,26],[54,59],{"name":55,"role":56,"phone":57,"phoneExt":36,"email":58},"Weili Zhao Zhao","CONTACT","+862164370045 Ext. 610707","zwl_trial@163.com",{"name":60,"role":56,"phone":61,"phoneExt":62,"email":63},"Pengpeng Xu","+862164370045","610707","pengpeng_xu@126.com",[65],{"facility":5,"status":36,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Shanghai","Shanghai Municipality","200025","China","CN",{"type":72,"coordinates":73},"Point",[74,75],121.45806,31.22222,{"lat":75,"lon":74},[78],{"name":79,"role":56,"phone":80,"phoneExt":81,"email":82},"Mingci Cai","86-21-64370045","665251","cmc12399@rjh.com.cn",{"type":84,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"PRINCIPAL_INVESTIGATOR","Zhao Weili","Vice President, Ruijin Hospital","100647374","phase-1-new-genotype-guided-treatment-in-newly-diagnosed-ptcl-100647374",false,"NCT07706959","New Genotype-guided Treatment in Newly Diagnosed PTCL","A New Genotype-guided Therapy in Newly Diagnosed Patients With Peripheral T-cell Lymphoma","G08","Inclusion Criteria:\n\n* Histologically-confirmed Peripheral T-cell lymphoma\n* Availability of archival or freshly collected tumor tissue before study enrollment enough for NGS\n* Evaluable lesion by PET-CT or CT scan\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2\n* Life expectancy greater than or equal to (\\>\u002F=) 3 months\n* Informed consent\n\nExclusion Criteria:\n\n* Patients with ALCL and cutaneous TCL, MEITL, HSTCL, T-PLL, etc.\n* Patients with central nervous system (CNS) lymphoma\n* History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix\n* Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases\n* Laboratory measures meet the following criteria at screening (unless caused by lymphoma):\n\nNeutrophils\\\u003C1.5×10\\^9\u002FL Platelets\\\u003C75×10\\^9\u002FL (Neutrophils\\\u003C1.0×10\\^9\u002FL, Platelets\\\u003C50×10\\^9\u002FL in case of bone marrow involvement) ALT or AST is 2.5 times higher than the upper limits of normal (ULN), AKP and bilirubin are 1.5 times higher than the ULN.\n\nCreatinine is 1.5 times higher than the ULN.\n\n* HIV-infected patients\n* Active hepatitis infection\n* Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol\n* Pregnant or lactation\n* Other medical conditions determined by the researchers that may affect the study","ALL","18 Years","75 Years",{"count":99,"type":100},108,"ESTIMATED","INTERVENTIONAL",[103,104],"PHASE1","PHASE2","This is a phase I\u002FII study evaluate the safety and efficacy targeted agents in combination with standard CHOP in new genotypic subtypes in treatment naive peripheral T-cell lymphoma. Phase I is to confirm RP2D of targeted agent. Phase II is a multicenter, prospective, randomized, open-label, controlled design to evaluate the efficacy and safety of new genotype-guided targeted agents plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP-X2) versus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with peripheral T-cell lymphoma.",[107],"Peripheral T-cell Lymphoma (PTCL)",[109,110,111,112],"Biomarker-driven","Genetic subtypes","Precision medicine","Peripheral T Cell Lymphoma","NOT_YET_RECRUITING","2026-07-11",{"date":116,"type":117},"2026-07-16","ACTUAL",{"date":119,"type":100},"2026-07",{"date":121,"type":100},"2029-07",{"name":5,"class":6},1]