[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600147":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":31,"locations":37,"responsibleParty":51,"collaborators":22,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":22,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":22,"enrollmentInfo":63,"targetDuration":22,"studyType":66,"phases":67,"briefSummary":70,"conditions":71,"keywords":22,"overallStatus":40,"whyStopped":22,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Golidocitinib Combined with Mitoxantrone Hydrochloride Liposome or GemOx","EXPERIMENTAL","In Cohort 1, patients will receive 150mg of Golidocitinib, orally once daily (qd), in combination with Mitoxantrone Hydrochloride Liposome, with an initial dose of 15mg\u002Fm² of Liposomal Mitoxantrone. Two dose groups are designed: 15mg\u002Fm² and 18mg\u002Fm². Each treatment cycle is 28 days. The Mitoxantrone Hydrochloride Liposome injection will be combined with Golidocitinib(150mg, qd) at the RP2D dose level for an extension study.\n\nIn Cohort 2, patients will receive 150mg of Golidocitinib, orally once daily (qd), in combination with Chidamide, with an initial dose of 20 mg (biw) of Chidamide. Two dose groups are designed: 20 mg and 30 mg. Each treatment cycle is 28 days. The Chidamide will be combined with Golidocitinib (150mg, qd) at the RP2D dose level for an extension study.",[13,14,15],"Drug: Golidocitinib","Drug: Mitoxantrone Hydrochloride Liposome","Drug: Chidamide",[17,23,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Golidocitinib","150mg, po, qd;",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"Mitoxantrone Hydrochloride Liposome","Cohort 1: 15 mg\u002Fm2, IV, D1 and 18 mg\u002Fm2, IV, D1 (phase Ib); RP2D (II study)",[9],{"type":18,"name":28,"description":29,"armGroupLabels":30,"otherNames":22},"Chidamide","Cohort 2: Chidamide：20mg\u002F30mg, po, Biw (phase Ib); RP2D (phase II study)",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":22,"email":36},"Qingqing Cai","CONTACT","+862087342823","caiqq@sysucc.org.cn",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":22,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":22},"Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University","RECRUITING","Guangzhou","Guangdong","China","CN",{"type":46,"coordinates":47},"Point",[48,49],113.25,23.11667,{"lat":49,"lon":48},{"type":52,"investigatorFullName":33,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","MD. PhD.","100600147","phase-1-golidocitinib-combined-with-mitoxantrone-hydrochloride-liposome-or-chidamide-in-the-treatment-of-relapsed-or-refractory-peripheral-t-cell-lymphoma-100600147",false,"NCT07093710","Golidocitinib Combined With Mitoxantrone Hydrochloride Liposome or Chidamide in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma","The Safety and Efficacy of Golidocitinib Combined With Mitoxantrone Hydrochloride Liposome or Chidamide in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma: A Prospective, Multicenter, Open-label, Phase Ib\u002FII Clinical Study","Inclusion Criteria:\n\n* Voluntarily participate in the clinical study; fully understand and be informed about the study and sign the Informed Consent Form (ICF); willing to comply with and capable of completing all trial procedures;\n* Diagnosed with PTCL according to the 2022 revised WHO lymphoma classification standards based on pathological diagnosis by the research center\n* Using the Lugano 2014 lymphoma efficacy evaluation criteria, the patient must have at least one measurable or evaluable lesion\n* Age ≥ 18 years\n* Expected survival greater than 12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Adequate organ and bone marrow function\n\nExclusion Criteria:\n\n* Accompanied by hemophagocytic lymphohistiocytosis (HLH)\n* Lymphoma involvement in the central nervous system or meninges\n* Active infections\n* Uncontrolled clinical cardiac symptoms or diseases\n* Currently using (or unable to stop at least one week prior to the first dose) a known CYP3A strong inducer or strong inhibitor.\n* Currently using vitamin K antagonists, antiplatelet drugs, anticoagulants (or unable to stop them within one week prior to the start of the study treatment).\n* History of Human Immunodeficiency Virus (HIV) infection and\u002For Acquired Immunodeficiency Syndrome (AIDS).\n* Patients with mental disorders or those unable to provide informed consent","ALL","18 Years",{"count":64,"type":65},101,"ESTIMATED","INTERVENTIONAL",[68,69],"PHASE1","PHASE2","This is a prospective, multicenter, open-label, phase Ib\u002FII clinical study to evaluate the safety and efficacy of golidocitinib combined with mitoxantrone hydrochloride liposome or chidamide in the treatment of relapsed or refractory peripheral T-cell lymphoma",[72],"Peripheral T Cell Lymphoma","2025-12-26",{"date":75,"type":76},"2025-12-31","ACTUAL",{"date":78,"type":76},"2025-08-27",{"date":80,"type":65},"2029-08-01",{"name":5,"class":6},1]