[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610969":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":26,"studyPopulation":26,"armGroups":33,"interventions":46,"overallOfficials":55,"centralContacts":59,"locations":68,"responsibleParty":107,"collaborators":26,"id":111,"slug":26,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":26,"eligibilityCriteria":116,"healthyVolunteers":112,"sex":117,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":26,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":71,"whyStopped":26,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"St. Petersburg State Pavlov Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of adverse events","To compare the safety of therapy use in the Nivo-AVD and Standard cohorts: analysis of the incidence, severity and spectrum of adverse events (according to CTCAE v5.0 criteria)","Up to 24 months from thetreatment start",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Progression-free survival","To compare progression-free survival in the Nivo-AVD and Standard cohorts","12, 24 and 36 months after completion of therapy",{"measure":19,"description":20,"timeFrame":21},"Response rates","To compare the rates of objective response, complete and partial responses after 2 and 6 courses of therapy in the Nivo-AVD and Standard cohorts by whole-body PET-CT (according to Lugano criteria for chemotherapy and LYRIC criteria for immunochemotherapy)","after 2 cycles of nivo and 2 cycles of Nivo-AVD (3 months from therapy initiation) and at the end of treatment (7 months from therapy initiation) and, in Standard cohorts, after 2 cycles and EOT of BEACOPPesc (2 and 6 months)",{"measure":23,"description":24,"timeFrame":25},"Overall survival","\\- To compare overall survival at 12, 24, and 36 months after completion of therapy in the Nivo-AVD and Standard cohorts.","12, 24, and 36 months after completion of therapy",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":26},"NONE",[34,40],{"label":35,"type":36,"description":37,"interventionNames":38},"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)",[39],"Drug: Nivo-AVD",{"label":41,"type":42,"description":43,"interventionNames":44},"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)",[45],"Drug: BEACOPP-like",[47,51],{"type":48,"name":35,"description":49,"armGroupLabels":50,"otherNames":26},"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;",[35],{"type":48,"name":52,"description":53,"armGroupLabels":54,"otherNames":26},"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)",[41],[56],{"name":57,"affiliation":5,"role":58},"Natalia Mikhailova, MD, PhD","STUDY_CHAIR",[60,65],{"name":61,"role":62,"phone":63,"phoneExt":26,"email":64},"Liudmila Fedorova, MD, PhD","CONTACT","+78123386265","md.FedorovaL@gmail.com",{"name":66,"role":62,"phone":63,"phoneExt":26,"email":67},"Polina Kotseliabina, MD","polina.kotselyabina.med@gmail.com",[69,88,97],{"facility":70,"status":71,"city":72,"state":26,"zip":26,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"A.N.Bakulev Center for cardiovascular surgery of the Russian Ministry of Health","RECRUITING","Moscow","Russia","RU",{"type":76,"coordinates":77},"Point",[78,79],37.61781,55.75204,{"lat":79,"lon":78},[82,85],{"name":83,"role":62,"phone":26,"phoneExt":26,"email":84},"Olga Mukhortova, MD, PhD","olgamukhortova@yandex.ru",{"name":86,"role":62,"phone":26,"phoneExt":26,"email":87},"Maria Metelkina, MD","metelkina.masha@yandex.ru",{"facility":89,"status":71,"city":72,"state":26,"zip":26,"country":73,"countryCode":74,"cosmosGeoPoint":90,"geoPoint":92,"contacts":93},"National Medical and Surgical Center named after N.I. Pirogov",{"type":76,"coordinates":91},[78,79],{"lat":79,"lon":78},[94],{"name":95,"role":62,"phone":26,"phoneExt":26,"email":96},"Vladislav Sarzhevskiy, MD, PhD","vladislavsarzhevsky@yandex.ru",{"facility":5,"status":71,"city":98,"state":26,"zip":26,"country":73,"countryCode":74,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Saint Petersburg",{"type":76,"coordinates":100},[101,102],30.31413,59.93863,{"lat":102,"lon":101},[105,106],{"name":66,"role":62,"phone":63,"phoneExt":26,"email":67},{"name":26,"role":62,"phone":63,"phoneExt":26,"email":26},{"type":108,"investigatorFullName":109,"investigatorTitle":110,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Ivan S Moiseev","Vice-director of RM Gorbacheva Research Institute","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":121,"type":122},178,"ESTIMATED","INTERVENTIONAL",[125],"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",[128],"Hodgkin Lymphoma",[128,130,131,132,133],"N-AVD","nuvolumab","BEACOPPesc","Low dose nivolumab","2026-03-31",{"date":136,"type":137},"2026-04-01","ACTUAL",{"date":139,"type":137},"2024-10-14",{"date":141,"type":122},"2030-10",{"name":5,"class":6},3]