[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ebv-positive-diffuse-large-b-cell-lymphoma-nos\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ebv-positive-diffuse-large-b-cell-lymphoma-nos":27},{"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":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100587220","phase-2-brentuximab-vedotin-combined-with-r-chp-in-newly-diagnosed-ebv-dlbcl-nos-100587220",false,"NCT06925555","Brentuximab Vedotin Combined With R-CHP in Newly Diagnosed EBV+ DLBCL-NOS","A Multi-center，Single-arm, Open-label Phase II Clinical Study on Brentuximab Vedotin Combined With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) in the Treatment of Newly Diagnosed EBV-positive Diffuse Large B-cell Lymphoma, Not Otherwise Specified (EBV+ DLBCL-NOS)","Inclusion Criteria:\n\n\\- Patients must meet all of the following inclusion criteria to be eligible for enrollment:\n\n1. BV+DLBCL, NOS diagnosed by pathological diagnosis according to WHO 2016 classification criteria;\n2. Sign the informed consent form;\n3. Systemic PET\u002FCT performed within 28 days prior to enrollment demonstrating at least one measurable lesion in two perpendicular dimensions (nodal lesion: longest diameter \\>15 mm, short axis \\>5 mm; extranodal lesion: longest diameter \\>10 mm) per Lugano 2014 criteria;\n4. ECOG Performance Status (PS) of 0-2;\n5. Adequate organ and bone marrow function defined as:\n\n   * Hematology: Absolute neutrophil count (ANC) ≥1.0×10⁹\u002FL, platelet count (PLT) ≥50×10⁹\u002FL, hemoglobin (HGB) ≥8.0 g\u002FdL; without granulocyte colony-stimulating factor, platelet transfusion, or red blood cell transfusion within 7 days prior to testing.\n   * Liver function: Total bilirubin (TBIL) ≤1.5×ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN.\n   * Renal function: Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance rate (CCR) ≥50 mL\u002Fmin.\n   * Cardiac function: NYHA class \\\u003CIII; left ventricular ejection fraction (LVEF) ≥50% by echocardiography.\n   * Coagulation: International normalized ratio (INR) ≤1.5×ULN, activated partial thromboplastin time (APTT) ≤ULN +10 s, prothrombin time (PT) ≤ULN +3 s.\n   * Thyroid function: Baseline thyroid-stimulating hormone (TSH) within normal range or abnormal TSH with normal T3\u002FT4 levels and no clinical symptoms.\n6. Expected survival ≥ 3 months.\n7. Age 18-70 years.\n8. For subjects of childbearing potential or with partners of childbearing potential: Agreement to use highly effective contraception during treatment and for 90 days after the last dose.\n\nExclusion Criteria:\n\n* Patients who meet any of the following criteria will be excluded from the study：\n\n  1. Central nervous system (CNS) involvement.\n  2. Second primary malignancy (except cured non-melanoma skin cancer, superficial bladder cancer, cervical carcinoma in situ, gastrointestinal intramucosal carcinoma, or breast cancer with no recurrence within 5 years).\n  3. History of severe allergic diseases, hypersensitivity to macromolecular protein preparations, or any component of Brentuximab Vedotin.\n  4. Prior allogeneic organ transplant or hematopoietic stem cell transplantation.\n  5. Concurrent systemic anti-tumor therapy during the study.\n  6. Anti-cancer vaccines or immunostimulatory anti-tumor therapy within 3 months prior to enrollment.\n  7. Active severe acute\u002Fchronic infection requiring systemic therapy.\n  8. Active or history of autoimmune disease within 2 years (exceptions: vitiligo, psoriasis, alopecia, Graves' disease without systemic treatment in the past 2 years; hypothyroidism requiring thyroid hormone replacement only; type I diabetes controlled with insulin).\n  9. Systemic immunosuppressive therapy within 4 weeks prior to enrollment (excluding topical\u002Fnasal\u002Finhaled corticosteroids or physiologic doses ≤10 mg\u002Fday prednisone equivalent).\n  10. Positive serology for HIV antibody (HIV-Ab), Treponema pallidum antibody (TP-Ab), HCV antibody (HCV-Ab); HBsAg-positive with HBV DNA \\>ULN.\n  11. History of idiopathic pulmonary fibrosis or interstitial pneumonia.\n  12. Active tuberculosis.\n  13. Prior ≥Grade 3 immune-related adverse events from immunotherapy.\n  14. History of neurologic\u002Fpsychiatric disorders (e.g., epilepsy, dementia).\n  15. Administration of live vaccines (e.g., influenza, varicella) within 4 weeks prior to treatment or planned during the study.\n  16. History of alcohol\u002Fdrug abuse.\n  17. Pregnancy or lactation.\n  18. Participation in another interventional clinical trial within 1 month prior to enrollment.\n  19. Other factors deemed by investigators to potentially compromise efficacy\u002Fsafety assessments.","ALL","18 Years","70 Years",{"count":20,"type":21},25,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Evaluation of the Safety and Efficacy of Brentuximab Vedotin Combined With R-CHP in Newly Diagnosed EBV+ DLBCL-NOS.",[27,28],"EBV-Positive Diffuse Large B-Cell Lymphoma, Nos","Brentuximab Vedotin","NOT_YET_RECRUITING","2025-09-25",{"date":32,"type":33},"2025-09-30","ACTUAL",{"date":35,"type":21},"2025-09",{"date":37,"type":21},"2028-12-30",{"name":39,"class":40},"The First Affiliated Hospital with Nanjing Medical University","OTHER"]