[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559370":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":70,"centralContacts":75,"locations":83,"responsibleParty":96,"collaborators":98,"id":124,"slug":125,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":36,"eligibilityCriteria":130,"healthyVolunteers":126,"sex":131,"minAge":132,"maxAge":133,"enrollmentInfo":134,"targetDuration":36,"studyType":137,"phases":138,"briefSummary":141,"conditions":142,"keywords":36,"overallStatus":86,"whyStopped":36,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"Children's Cancer Group, China","NETWORK",[8,19,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Low risk group","EXPERIMENTAL","Stage IA , no bulky Stage IIA, no bulky",[13,14,15,16,17,18],"Drug: Brentuximab Vedotin for Injection","Radiation: response-adapted radiation","Drug: Doxorubicin","Drug: Etoposide","Drug: Prednisone","Drug: Cyclophosphamide",{"label":20,"type":10,"description":21,"interventionNames":22},"Intermediate risk group","Stage IA, with bulky Stage IIA, with bulky Stage IB, with\u002Fwithout bulky Stage IAE, with\u002Fwithout bulky Stage IIAE, with\u002Fwithout bulky Stage IIIA, with\u002Fwithout bulky",[13,14,15,16,17,18,23,24,25],"Drug: Dacarbazine","Drug: Tislelizumab Injection","Drug: Bedamustine",{"label":27,"type":10,"description":28,"interventionNames":29},"High risk group","Stage IIB Stage IIIB Stage IV",[13,14,15,16,17,18,23,24,25],[31,37,42,46,50,54,58,62,66],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Brentuximab Vedotin for Injection","1.8mg\u002Fkg\u002Fdose (MAX 180 mg)",[27,20,9],null,{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":36},"RADIATION","response-adapted radiation","For patients who did not achieve complete metabolic response at early response assessment based on PET\u002FCT result.",[27,20,9],{"type":32,"name":43,"description":44,"armGroupLabels":45,"otherNames":36},"Doxorubicin","25mg\u002Fm2\u002Fdose,",[27,20,9],{"type":32,"name":47,"description":48,"armGroupLabels":49,"otherNames":36},"Etoposide","125 mg\u002Fm2\u002Fdose",[27,20,9],{"type":32,"name":51,"description":52,"armGroupLabels":53,"otherNames":36},"Prednisone","20 mg\u002Fm2, BID, orally",[27,20,9],{"type":32,"name":55,"description":56,"armGroupLabels":57,"otherNames":36},"Cyclophosphamide","600 mg\u002Fm2\u002Fdose",[27,20,9],{"type":32,"name":59,"description":60,"armGroupLabels":61,"otherNames":36},"Dacarbazine","250 mg\u002Fm2\u002Fdose; For patients in intermediate\u002Fhigh risk group who did not achieve complete metabolic response at early assessment based on PET\u002FCT results.",[27,20],{"type":32,"name":63,"description":64,"armGroupLabels":65,"otherNames":36},"Tislelizumab Injection","3mg\u002Fkg\u002Fdose; For patients in intermediate\u002Fhigh risk group who did not achieve complete metabolic response at late assessment based on PET\u002FCT results.",[27,20],{"type":32,"name":67,"description":68,"armGroupLabels":69,"otherNames":36},"Bedamustine","180mg\u002Fm2\u002Fdose; For patients in intermediate\u002Fhigh risk group who did not achieve complete metabolic response at late assessment based on PET\u002FCT results.",[27,20],[71],{"name":72,"affiliation":73,"role":74},"YI JIN GAO, MD","Shanghai Children's Medical Center","PRINCIPAL_INVESTIGATOR",[76,80],{"name":72,"role":77,"phone":78,"phoneExt":36,"email":79},"CONTACT","86-21-38087513","gaoyijin@scmc.com.cn",{"name":81,"role":77,"phone":36,"phoneExt":36,"email":82},"JIE ZHAO","zhaojie@scmc.com.cn",[84],{"facility":85,"status":86,"city":87,"state":36,"zip":36,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":36},"Shanghai Children's Medical Center","RECRUITING","Shanghai","China","CN",{"type":91,"coordinates":92},"Point",[93,94],121.45806,31.22222,{"lat":94,"lon":93},{"type":97,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[99,101,104,106,108,110,112,114,116,118,120,122],{"name":85,"class":100},"OTHER",{"name":102,"class":103},"Najing Children's Hospital","UNKNOWN",{"name":105,"class":100},"West China Second University Hospital",{"name":107,"class":100},"Qilu Hospital of Shandong University",{"name":109,"class":100},"Tianjin Medical University Cancer Institute and Hospital",{"name":111,"class":100},"Tongji Hospital",{"name":113,"class":100},"Xiangya Hospital of Central South University",{"name":115,"class":100},"The First Affiliated Hospital of Zhengzhou University",{"name":117,"class":100},"The Second Hospital of Anhui Medical University",{"name":119,"class":100},"Children's Hospital of Hebei Province",{"name":121,"class":103},"Children's Hospital of Henan Province",{"name":123,"class":100},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","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":135,"type":136},96,"ESTIMATED","INTERVENTIONAL",[139,140],"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.",[143,144,145,146,147,148,149,150,151],"Classical Hodgkin Lymphoma","Child","Adolescent","Young Adult","Metabolic Response","Survival","Treatment","Brentuximab Vedotin","PET Scan","2026-03-17",{"date":154,"type":155},"2026-03-19","ACTUAL",{"date":157,"type":155},"2024-09-25",{"date":159,"type":136},"2039-11-15",{"name":5,"class":6},1]