[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587220":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":48,"collaborators":20,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":20,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":20,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":20,"overallStatus":71,"whyStopped":20,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"BV+R-CHP Arm","EXPERIMENTAL","Newly Diagnosed EBV+ DLBCL-NOS Patients Receiving Brentuximab Vedotin plus R-CHP(Rituximab、Cyclophosphamide、Doxorubicin and Prednisone)",[13],"Drug: BV+R-CHP",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","BV+R-CHP","Brentuximab Vedotin, 1.8mg\u002Fkg\u002Fdose, d0、Rituximab, 375 mg\u002Fm2, d0、Cyclophosphamide, 750 mg\u002Fm2, d1、Doxorubicin, 50 mg\u002Fm2, d1、Prednisone, 60mg\u002Fm2, d1-5",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Wei Xu, Doctor","CONTACT","86-2568302182","xuwei10000@hotmail.com",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Liang Jinhua, M.D","15952032421","1151525490@qq.com",[32],{"facility":5,"status":20,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Nanjing","Jiangsu","210000","China","CN",{"type":39,"coordinates":40},"Point",[41,42],118.77778,32.06167,{"lat":42,"lon":41},[45],{"name":46,"role":24,"phone":47,"phoneExt":20,"email":26},"WEI XU","86-25-68302182",{"type":49,"investigatorFullName":46,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","M.D","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":62,"type":63},25,"ESTIMATED","INTERVENTIONAL",[66],"PHASE2","Evaluation of the Safety and Efficacy of Brentuximab Vedotin Combined With R-CHP in Newly Diagnosed EBV+ DLBCL-NOS.",[69,70],"EBV-Positive Diffuse Large B-Cell Lymphoma, Nos","Brentuximab Vedotin","NOT_YET_RECRUITING","2025-09-25",{"date":74,"type":75},"2025-09-30","ACTUAL",{"date":77,"type":63},"2025-09",{"date":79,"type":63},"2028-12-30",{"name":5,"class":6},1]