[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610969":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":82,"collaborators":25,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":25,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":25,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"St. Petersburg State Pavlov Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Nivo-AVD","EXPERIMENTAL","Nivo-AVD cohort patients will receive 2 cycles of nivolumab monotherapy (40 mg) followed by Nivo-AVD combination therapy (6 cycles total)",[13],"Drug: Nivo-AVD",{"label":15,"type":16,"description":17,"interventionNames":18},"BEACOPP-like regimes - Standard cohort","ACTIVE_COMPARATOR","In the Standard cohort, patients will receive therapy according to current clinical guidelines for first-line therapy of cHL, which include starting first-line therapy with 2 cycles of BEACOPP-like regimens and, after assessing response after 2 courses, switching to an A(B)VD regimen (when achieving CR by PET\u002FCT) or continuing therapy with BEACOPP-like regimens (when achieving PR,SD by PET\u002FCT)",[19],"Drug: BEACOPP-like",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","1. Monotherapy phase - Nivolumab - 40 mg every 14 days x 2 cycles\n2. Combination therapy phase - Nivo-AVD x 6 cycles Nivolumab - 40 mg every 14 days; Doxorubicin 25 mg\u002Fm2 in D1 and 15; Vinblastine 6 mg\u002Fm2 (no more than 10 mg) in D 1 and 15; Dacarbazine 375 mg\u002Fm2 in D 1 and 15;",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"BEACOPP-like","* BEACOPP-like regimens x 2 cycles + BEACOPP-like regimens x 4 (for patients with PR, SD by PET\u002FCT after 2 cycles)\n* BEACOPP-like regimens x 2 + A(B)VD x 4 cycles (for patients with CR by PET\u002FCT after 2 cycles)",[15],[31],{"name":32,"affiliation":5,"role":33},"Natalia Mikhailova, MD, PhD","STUDY_CHAIR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Liudmila Fedorova, MD, PhD","CONTACT","+78123386265","md.FedorovaL@gmail.com",{"name":41,"role":37,"phone":38,"phoneExt":25,"email":42},"Polina Kotseliabina, MD","polina.kotselyabina.med@gmail.com",[44,63,72],{"facility":45,"status":46,"city":47,"state":25,"zip":25,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"A.N.Bakulev Center for cardiovascular surgery of the Russian Ministry of Health","RECRUITING","Moscow","Russia","RU",{"type":51,"coordinates":52},"Point",[53,54],37.61781,55.75204,{"lat":54,"lon":53},[57,60],{"name":58,"role":37,"phone":25,"phoneExt":25,"email":59},"Olga Mukhortova, MD, PhD","olgamukhortova@yandex.ru",{"name":61,"role":37,"phone":25,"phoneExt":25,"email":62},"Maria Metelkina, MD","metelkina.masha@yandex.ru",{"facility":64,"status":46,"city":47,"state":25,"zip":25,"country":48,"countryCode":49,"cosmosGeoPoint":65,"geoPoint":67,"contacts":68},"National Medical and Surgical Center named after N.I. Pirogov",{"type":51,"coordinates":66},[53,54],{"lat":54,"lon":53},[69],{"name":70,"role":37,"phone":25,"phoneExt":25,"email":71},"Vladislav Sarzhevskiy, MD, PhD","vladislavsarzhevsky@yandex.ru",{"facility":5,"status":46,"city":73,"state":25,"zip":25,"country":48,"countryCode":49,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Saint Petersburg",{"type":51,"coordinates":75},[76,77],30.31413,59.93863,{"lat":77,"lon":76},[80,81],{"name":41,"role":37,"phone":38,"phoneExt":25,"email":42},{"name":25,"role":37,"phone":38,"phoneExt":25,"email":25},{"type":83,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Ivan S Moiseev","Vice-director of RM Gorbacheva Research Institute","100610969","phase-2-comparison-of-avd--low-dose-nivolumab-vs-pet-adapted-beacopp-like-in-advanced-chl-100610969",false,"NCT07234487","Comparison of AVD + Low-Dose Nivolumab vs. PET-Adapted BEACOPP-like in Advanced cHL","Randomized Study Comparing AVD Combined With Fixed-Dose Nivolumab Versus PET-Adapted BEACOPP-like Regimen as First-Line Treatment in Advanced Classical Hodgkin Lymphoma","Inclusion Criteria:\n\n* Patients with newly diagnosed histologically confirmed stage IIB, III or IV classical hodgkin lymphoma who have not previously received specific therapy;\n* Patients with evidence of lesion extent assessed by whole-body PET\u002FCT;\n* Patients aged 18-60 years;\n* ECOG 0-2;\n* Use of highly effective contraceptive methods from the moment of signing the informed consent form, throughout the study and within 6 months after receiving the last dose of the drug;\n\nExclusion Criteria:\n\n* Severe organ failure: creatinine \\> 2 norms; alanine aminotransferase, aspartate aminotransferase \\> 5 norms; bilirubin\\> 1.5 norms;\n* Respiratory failure \\> grade 1 at the time of enrollment\n* Requirement for vasopressor support at the time of enrollment\n* Uncontrolled bacterial or fungal infection at the time of enrollment\n* Active or prior documented autoimmune disease requiring systemic treatment\n* Pregnancy, breastfeeding, planning pregnancy or parenthood during the study period\n* Hypersensitivity or allergy to study drugs\n* Somatic or mental pathology that does not allow to perform research procedures, including the signing of informed consent\n* Simultaneous use of drugs or medical devices studied in other clinical trials","ALL","18 Years","60 Years",{"count":97,"type":98},178,"ESTIMATED","INTERVENTIONAL",[101],"PHASE2","Patients in this prospective multicenter phase II study will be randomized between two first-line therapy strategies for advanced stages of cHL. In the Nivo-AVD cohort, patients will receive 2 cycles of nivolumab monotherapy followed by a switch to Nivo-AVD combination therapy (total of 6 cycles); in the Standard cohort, patients will receive therapy according to current clinical guidelines in Russian Federation for first-line therapy of cHL, which include starting first-line therapy with 2 cycles of BEACOPP-like regimens and, after assessing response after 2 courses, switching to A(B)VD or continuing with BEACOPP-like regimens",[104],"Hodgkin Lymphoma",[104,106,107,108,109],"N-AVD","nuvolumab","BEACOPPesc","Low dose nivolumab","2026-03-31",{"date":112,"type":113},"2026-04-01","ACTUAL",{"date":115,"type":113},"2024-10-14",{"date":117,"type":98},"2030-10",{"name":5,"class":6},3]