[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brentuximab-vedotin\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brentuximab-vedotin":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,76],{"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":26,"conditions":27,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100559370","phase-2-brentuximab-vedotin-for-newly-diagnosed-chl-in-chinese-caya-based-on-petct-assessment-100559370",false,"NCT06563245","Brentuximab Vedotin for Newly Diagnosed cHL in Chinese CAYA Based on PET\u002FCT Assessment","A Phase II\u002FIII Study of Brentuximab Vedotin for Newly Diagnosed Classical Hodgkin Lymphoma in Chinese CAYA Based on PET\u002FCT Assessment","Inclusion Criteria:\n\n* Ages \\>=2\\~\\\u003C35 years at the time of enrollment;\n* Patients with newly diagnosed, pathologically confirmed classical Hodgkin lymphoma (HL) by at least 2 tertiary referral centers for pathology;\n* Adequate organ function;\n* Patients and\u002For their parents or legal guardians sign a written informed consent;\n\nExclusion Criteria:\n\n* Patients with nodular lymphocyte-predominant HL;\n* Patients with an immunodeficiency that existed prior to diagnosis; such as primary immunodeficiency syndromes, organ transplant recipients and children on current systemic immunosuppressive agents are not eligible;Patients known to be positive for HIV are not eligible.\n* Patients who are pregnant; Lactating females who plan to breastfeed.\n* Patients who received systemic corticosteroids within 28 days of enrollment on this protocol","ALL","2 Years","35 Years",{"count":20,"type":21},96,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","Generally, pediatric patients tolerate acute toxicities but are vulnerable to late effects. Thus, increasing chemotherapy intensity to achieve more rapid complete early response to limit radiation therapy is worth testing. In this CCCG-HL-2024 study, Brentuximab vedotin (Bv) was used to replace VCR and bleomycin in the ABVE-PC regimen in the previous CCCG-HD-2018 study, respectively, to form a Bv-AEPC regimen for the treatment of newly diagnosed classic Hodgkin lymphoma (cHL) in children, adolescents and young adults. On the premise of maintaining a 4-year event free survival (EFS)\\>90% in the low-, intermediate-and high-risk groups, increase the early assessment complete response rate (the overall early complete response rate increased by 20%, that is, from 54.0% to 74.0%) to further reduce the proportion of children receiving radiotherapy to benefit them.",[28,29,30,31,32,33,34,35,36],"Classical Hodgkin Lymphoma","Child","Adolescent","Young Adult","Metabolic Response","Survival","Treatment","Brentuximab Vedotin","PET Scan","RECRUITING","2026-03-17",{"date":40,"type":41},"2026-03-19","ACTUAL",{"date":43,"type":41},"2024-09-25",{"date":45,"type":21},"2039-11-15",{"name":47,"class":48},"Children's Cancer Group, China","NETWORK",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":49},"100587220","phase-2-brentuximab-vedotin-combined-with-r-chp-in-newly-diagnosed-ebv-dlbcl-nos-100587220","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.","18 Years","70 Years",{"count":60,"type":21},25,[24],"Evaluation of the Safety and Efficacy of Brentuximab Vedotin Combined With R-CHP in Newly Diagnosed EBV+ DLBCL-NOS.",[64,35],"EBV-Positive Diffuse Large B-Cell Lymphoma, Nos","NOT_YET_RECRUITING","2025-09-25",{"date":68,"type":41},"2025-09-30",{"date":70,"type":21},"2025-09",{"date":72,"type":21},"2028-12-30",{"name":74,"class":75},"The First Affiliated Hospital with Nanjing Medical University","OTHER",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":58,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":4},"100606661","phase-3-brentuximab-vedotin-in-cutaneous-t-cell-lymphomas-ctcl-post-allogeneic-hematopoietic-stem-cell-transplant-maintenance-100606661","NCT07178457","Brentuximab Vedotin in CutAneous T-cell Lymphomas (CTCL): Post-allogeneic Hematopoietic Stem Cell Transplant Maintenance","BeCALM","Inclusion Criteria:\n\nTo be eligible for study entry, patients must meet all of the following criteria:\n\n* Age ≥ 18 and ≤ 70 years\n* Histopathologically confirmed diagnosis of ISCL-EORTC stage IIB, III, IVA or IVB MF (mycosis fungoides) with ≥1% CD30 expression determined by immunohistochemistry\n* ECOG performance status 0-1\n* Relapsed or refractory to at least one line of systemic treatment\n* Complete or partial response of the lymphoma at the time of study inclusion\n* Having received recent alloHSCT from a sibling, 10\u002F10 or 9\u002F10 phenoidentical, or haploidentical donor (60 to 90 days before inclusion)\n* Adequate liver function:\n\n  * Total bilirubin ≤ 2 xULN, or Direct bilirubin ≤ 2xULN if total bilirubin is \\>2xULN, or total bilirubin \\>2 xULN if elevated total bilirubin is attributed to Gilbert's syndrome\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN\n* Adequate hematological function:\n\n  * Absolute neutrophil count of ≥ 1.0 G\u002FL\n  * Platelet count of ≥ 50 G\u002FL\n  * Hemoglobin ≥ 9 g\u002FdL\n* Adequate renal function: creatinine clearance calculated by Cockcroft \\& Gault formula of ≥ 50 mL\u002Fmin\n* Patient affiliated to life insurance\n* Written informed consent given by the patient\n\nExclusion Criteria:\n\nAny of the following criteria requires the exclusion of the patient before randomization:\n\n* Second or higher allogeneic HSCT,\n* Other progressive neoplastic or psychotic disease,\n* Left ventricular ejection fraction \\\u003C 50%, carbone monoxide diffusion capacity \\\u003C 50% of the theoretical value,\n* History of BV-induced adverse event without resolution to current grade \\\u003C2. Previous treatment with brentuximab vedotin alone, in the absence of current ≥ grade 2 BV-induced side effect, is NOT an exclusion criterion.\n* History of disease refractoriness, progression or relapse during BV treatment. Previous treatment with BV alone, if the disease was treatment-sensitive (complete, partial response or stable disease), is NOT an exclusion criterion.\n* History of ≥ grade 4 adverse event induced by BV. Previous \\\u003Cgrade 4 adverse event induced by BV is not an exclusion criterion if the adverse event has regressed to grade\\\u003C2.\n* Contra-indication to BV including current \\>grade 2 neutropenia or active infection,\n* Progressive disease or relapse at study inclusion compared to the screening visit status,\n* Refusal of highly effective birth control method for female participant of childbearing potential and male participant with a female partner of childbearing potential,\n* Pregnant and\u002For breastfeeding women,\n* Participation to another interventional clinical trial,\n* Adults subject to a legal protection measure (guardianship, curatorship and safeguard of justice),\n* Patients deprived of their liberty by a judicial or administrative decision",{"count":84,"type":21},84,[25],"Allogeneic hematopoietic stem cell transplantation (alloHSCT) showed efficacy in advanced-stage, high-risk, treatment sensitive cutaneous T-cell lymphomas (CTCL) in a prospective, propensity score-matched controlled study (CUTALLO) published by our group in the Lancet in 2023. Nevertheless, it is associated with a high rate of early relapse, with 2-year progression-free survival around 30%. Brentuximab vedotin (BV) has shown efficacy in the treatment of CD30-expressing CTCL after at least one prior systemic treatment in the ALCANZA trial and is market approved in this indication in Europe and the United States of America. BV has been successfully used as salvage treatment in the post-transplant setting in advanced CTCL. It has been shown that 90% of CTCL express CD30. To reduce the incidence of post-allograft relapse, we propose to assess the routine use of BV post-allograft in adult patients with advanced CD30-expressing mycosis fungoides-CTCL, who have received at least one line of prior systemic therapy, compared to placebo. Switch will be allowed from placebo to BV in case of disease progression. This project is supported by well-organized research networks with a strong track-record of published results in the field: French Study Group on Cutaneous Lymphomas (GFELC, Groupe Français d'Etude des Lymphomes Cutanés), INCa-labelled national rare cancers network; and the French Society of Bone Marrow Transplantation and CellTherapy. In the post-transplant setting, the current state-of-the-art practice is to treat patients once they have relapsed post-allogeneic transplant, whereas no prophylactic treatment is given at the time in the absence of characterized disease relapse. This ethically and scientifically justifies the proposal to evaluate whether earlier, prophylactic treatment with BV increases progression-free survival compared to placebo.",[88,35],"Cutaneous T Cell Lymphoma (CTCL)","2025-09-10",{"date":91,"type":41},"2025-09-17",{"date":93,"type":21},"2025-11-01",{"date":95,"type":21},"2032-11-01",{"name":97,"class":75},"Assistance Publique - Hôpitaux de Paris"]