[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cutaneous-t-cell-lymphomamycosis-fungoidesszary-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cutaneous-t-cell-lymphomamycosis-fungoidesszary-syndrome":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":5},"100658677","phase-2-a-prospective-clinical-study-of-zeprumetosta-in-patients-with-relapsed-or-refractory-cutaneous-t-cell-lymphoma-100658677",false,"NCT07854639","A Prospective Clinical Study of Zeprumetosta in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma","Inclusion Criteria:\n\n1. Age ≥18 years, regardless of sex;\n2. Mycosis fungoides or Sézary syndrome confirmed by histopathological examination;\n3. Patients with measurable disease, with or without extracutaneous involvement, and clinical stage IIB-IVB;\n4. Patients with no response or relapse after remission following at least one line of systemic therapy (including total-skin electron-beam irradiation, bexarotene, retinoids, interferons, extracorporeal photopheresis, methotrexate, chidamide, etc.);\n5. Adequate major organ function, meeting the following criteria: a) Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN) in patients without liver metastasis; b) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; c) Creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance (Ccr) ≥ 50 mL\u002Fmin (calculated by the Cockcroft-Gault formula);\n6. Adequate bone marrow function: absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL, platelet count (PLT) ≥ 80 × 10\\^9\u002FL, and hemoglobin (HGB) ≥ 90 g\u002FL;\n7. ECOG performance status ≤ 2;\n8. Willingness not to participate in other interventional studies during the treatment period;\n9. Voluntary provision of written informed consent, understanding of the nature, purpose, and procedures of the study, and willingness to comply with the study requirements.\n\nExclusion Criteria:\n\n1. Prior treatment with an EZH2 inhibitor or an EZH1\u002F2 inhibitor;\n2. Dysphagia or inability to receive oral medication due to gastrointestinal disorders;\n3. History of other primary invasive malignancies that are not resolved or have been in remission for ≤ 3 years;\n4. Known hypersensitivity to any medication used in the study;\n5. Participation in other investigational drug clinical trials within 4 weeks prior to study initiation;\n6. Concomitant use of known moderate or strong CYP3A4 or CYP3A5 inducers\u002Finhibitors, or P-gp inhibitors;\n7. History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency diseases, or history of organ transplantation;\n8. Patients who have undergone major surgery within 4 weeks prior to enrollment and have not fully recovered;\n9. Chronic respiratory disease requiring continuous oxygen therapy; history of clinically significant renal, neurological, psychiatric, endocrine, metabolic, immune, hepatic (decompensated cirrhosis Child-Pugh class B or C), or cardiovascular diseases; or any other disease that, in the investigator's judgment, may adversely affect the patient's participation in this study;\n10. Active, uncontrolled infections, including but not limited to: active hepatitis B (defined as positive HBsAg AND HBV DNA ≥ 2000 IU\u002FmL AND ALT ≥ 2 × ULN, with drug-induced or other causes of hepatitis excluded), hepatitis C (defined as positive anti-HCV antibody AND positive HCV RNA), human immunodeficiency virus (HIV) infection, or positive syphilis-specific antibody test;\n11. Pregnant or lactating women, or female patients planning to become pregnant during the study;\n12. History of stroke or intracranial hemorrhage within ≤ 6 months prior to the first dose of the study drug;\n13. Any other condition that, in the opinion of the investigator, makes the patient unsuitable for inclusion in the study.","ALL","18 Years",{"count":18,"type":19},33,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","Patients with relapsed or refractory cutaneous T-cell lymphoma (R\u002FR CTCL) face a poor prognosis and limited therapeutic options. Advanced or relapsed disease yields a 5-year overall survival rate of \\\u003C50%. Real-world data show that third-line therapy achieves an ORR of only 45-50% with a median PFS of 1.2 years. Chemotherapy remains dominant (43.1% in the third-line) but offers limited, transient efficacy (median time to next treatment: 4 months) and severe toxicities, leaving a critical unmet need for safe, highly specific targeted therapies.\n\nEpigenetic dysregulation is central to CTCL pathogenesis, particularly aberrations in the histone methyltransferase EZH2. As the catalytic subunit of PRC2, EZH2 mediates H3K27me3 to repress target gene transcription. In CTCL, EZH2 frequently undergoes copy number amplification or gain-of-function mutations to drive tumor progression. Targeting EZH2 demonstrates high tumor specificity; EZH2 inhibitors like tazemetostat and valemetostat are already approved for epithelioid sarcoma, follicular lymphoma, and peripheral T-cell lymphoma (PTCL). Preclinically, EZH2 is specifically overexpressed in neoplastic CTCL T cells, and EZH2 inhibitors dose-dependently suppress CTCL cell\u002Ftumor growth.\n\nGiven shared pathogenic mechanisms, PTCL data provide strong reference for CTCL. Valemetostat achieved an ORR of 43.7% and median PFS of 5.5 months in R\u002FR PTCL. Zeprumetostat demonstrated superior efficacy (ORR 61%, median PFS 11.1 months) with a favorable safety profile, leading to its 2025 approval in China for R\u002FR PTCL.\n\nTherefore, this single-arm, prospective trial evaluates zeprumetostat in R\u002FR CTCL. Given that CTCL shares essential pathogenetic and epigenetic features with PTCL, and leveraging zeprumetostat's established approval in PTCL, this study represents a rational and mechanistically justified therapeutic expansion rather than an unsupported off-label application.",[25],"Cutaneous T-Cell Lymphoma\u002FMycosis Fungoides\u002FSézary Syndrome","NOT_YET_RECRUITING","2026-09-27",{"date":29,"type":30},"2026-10-02","ACTUAL",{"date":32,"type":19},"2026-10-31",{"date":34,"type":19},"2028-05-30",{"name":36,"class":37},"Peking University First Hospital","OTHER"]