[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648633":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":11,"responsibleParty":25,"collaborators":11,"id":27,"slug":28,"hasResults":29,"nctId":30,"briefTitle":31,"officialTitle":32,"acronym":11,"eligibilityCriteria":33,"healthyVolunteers":29,"sex":34,"minAge":35,"maxAge":36,"enrollmentInfo":37,"targetDuration":11,"studyType":40,"phases":41,"briefSummary":44,"conditions":45,"keywords":48,"overallStatus":54,"whyStopped":11,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":11},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SHR2554 combined with Liposomal Mitoxantrone","EXPERIMENTAL",null,[13],"Drug: SHR2554 combined with Liposomal Mitoxantrone",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","Patients will receive 6 cycles of SHR2554 combined with liposomal mitoxantrone as induction therapy. All patients who achieve a complete response (CR) after induction therapy are eligible for transplantation. Patients achieving CR or partial response (PR), as well as those post-transplantation, may receive SHR2554 maintenance therapy in 28-day cycles. Maintenance therapy will continue until disease progression or other reasons for discontinuation. The maximum duration of SHR2554 administration in the maintenance phase will not exceed 24 months.",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Liang Huang","CONTACT","+86 022-23608126","huangliang@ihcams.ac.cn",{"type":26,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100648633","phase-1-shr2554-plus-liposomal-mitoxantrone-as-first-line-treatment-for-peripheral-t-cell-lymphoma-ptcl-100648633",false,"NCT07725705","SHR2554 Plus Liposomal Mitoxantrone as First-line Treatment for Peripheral T-cell Lymphoma (PTCL)","An Open-label, Multicenter, Phase Ib\u002FII Exploratory Clinical Study of EZH2 Inhibitor SHR2554 in Combination With Liposomal Mitoxantrone for the First-line Treatment of Peripheral T-cell Lymphoma","Inclusion Criteria:\n\n1. Age ≥18 years old,regardless of gender;\n2. Centrally confirmed histopathological\u002Fcytologic diagnosis of PTCL with the following subtypes:Peripheral T-cell lymphoma, not otherwise specified (PTCL, NOS);Follicular helper T (TFH) cell lymphoma of lymph nodes, including angioimmunoblastic, follicular, NOS; Enteropathy-associated T-cell lymphoma(EATL); Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL)and any other PTCL subtypes deemed by the investigator to be eligible for inclusion.\n3. No prior anti-tumor therapy.\n4. There must be at least one measurable or evaluable lesion that meets the Lugano 2014 criteria for lymphoma: Measurable lesion: Nodal lesions with major diameter greater than 1.5cm and minor diameter greater than 1.0cm as assessed by PET\u002FCT or Computed Tomography (CT) and\u002For Magnetic Resonance Imaging (MRI); Or the length of extranodal lesions \\>1.0cm; 2)Evaluable lesions: PET-CT showed increased uptake in lymph nodes or extranodal regions (higher than liver) and imaging features consistent with lymphoma;\n5. ECOG performance status score: 0-2;\n6. Expected survival time ≥3 months;\n7. Have adequate organ and bone marrow functiont;\n8. No concurrent hemophagocytic lymphohistiocytosis (HLH). If a patient has clinically diagnosed HLH, enrollment eligibility will be determined by the investigator based on an evaluation of the patient's general physical condition following targeted anti-HLH therapy.\n9. Women of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose of medication; Effective contraception should be used from the time of informed consent until 6 months after the last dose of study drug.\n10. Capable of understanding the study procedures and voluntarily signing a written informed consent form (ICF).;\n\nExclusion Criteria:\n\n1. Prior treatment with epigenetic agents before enrollment;\n2. Patients with a history of severe cardiac disease, history of radiation therapy to the mediastinal\u002Fpericardial region, cumulative anthracycline dose \\> 550 mg (doxorubicin equivalent), prior use of mitoxantrone, baseline left ventricular ejection fraction (LVEF) \\\u003C 50%, or history of exposure to other cardiotoxic drugs;\n3. History of other primary aggressive malignancies that are not in remission, or have been in remission for less than 3 years;\n4. Primary central nervous system (CNS) lymphoma or secondary CNS involvement.\n5. Known allergy or hypersensitivity to the study drugs or their related metabolites;\n6. Currently participating in another clinical study, or less than 4 weeks elapsed from the end of treatment in a previous clinical study to the planned start of study treatment;\n7. Pregnant or lactating women;\n8. Active infections;\n9. Medical History and Concurrent Conditions;\n10. History of Human Immunodeficiency Virus (HIV) infection and\u002For Acquired Immunodeficiency Syndrome (AIDS);\n11. Patients with mental disorders or those unable to provide informed consent\n12. Any other condition deemed by the investigator to be unsuitable for study enrollment;","ALL","18 Years","80 Years",{"count":38,"type":39},44,"ESTIMATED","INTERVENTIONAL",[42,43],"PHASE1","PHASE2","This is a single-arm, multicenter, Phase Ib\u002FIIa study designed to explore the efficacy and safety of SHR2554 in combination with liposomal mitoxantrone for the treatment of patients with treatment-naive peripheral T-cell lymphoma (PTCL). The study is divided into a Phase Ib safety lead-in phase and a Phase IIa dose expansion phase.",[46,47],"PTCL","First Line Treatment",[49,50,51,52,53],"EZH2 inhibitor","SHR2554","Liposomal Mitoxantrone","First-line Treatment of PTCL","Zeprumetostat","NOT_YET_RECRUITING","2026-07-21",{"date":57,"type":58},"2026-07-24","ACTUAL",{"date":60,"type":39},"2026-08-01",{"date":62,"type":39},"2030-03-01",{"name":5,"class":6}]