[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609015":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":37,"centralContacts":42,"locations":52,"responsibleParty":67,"collaborators":47,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":47,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":54,"whyStopped":47,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"National Research Center for Hematology, Russia","NETWORK",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Response-adapted immunochemotherapy (FINISH protocol)","EXPERIMENTAL","All participants receive induction immunochemotherapy with nivolumab and EACOPD-14 (2 cycles). Based on interim PET-CT after 2 cycles:\n\n1. PET-negative (Deauville 1-3): de-escalated consolidation with Nivolumab + AVD ×2, followed by nivolumab monotherapy ×2\n2. PET-positive (Deauville ≥4): continuation of Nivo-EACOPD-14 ×2 (total 4 cycles).\n\n2.1. If PET becomes negative after 4 cycles: consolidation with Nivo-EACOPD-14 ×2 2.2. If PET remains positive after 4 cycles: patient is withdrawn from the protocol\n\nCirculating tumor DNA (ctDNA) is collected at baseline, after 2, 4, and 6 cycles for exploratory molecular response assessment.",[13,14,15],"Drug: Nivolumab","Other: N-EACOPD-14","Other: N-AVD",[17,24,31],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Nivolumab","Monoclonal antibody targeting PD-1; administered in combination regimens",[9],[23],"Opdivo",{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"OTHER","N-EACOPD-14","14-day regimen. Combination of Nivolumab with Etoposide, Doxorubicin, Cyclophosphamide, Vincristine, Prednisone, and Dacarbazine; given for 2 cycles as initial therapy.",[9],[30],"Nivolumab + EACOPD",{"type":25,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"N-AVD","Combination of Nivolumab with Doxorubicin, Vinblastine, and Dacarbazine; used as de-escalated therapy after negative interim PET (2 cycles).",[9],[36],"Nivolumab + AVD",[38],{"name":39,"affiliation":40,"role":41},"Evgeny E Zvonkov, MD, PhD","National Medical Research Center for Hematology","STUDY_DIRECTOR",[43,49],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},"Anna A Kravtsova, MD","CONTACT","+74956122361",null,"kravtsovaanna95@gmail.com",{"name":50,"role":45,"phone":46,"phoneExt":47,"email":51},"Yana K Mangasarova, MD","v.k.jana@mail.ru",[53],{"facility":40,"status":54,"city":55,"state":47,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"RECRUITING","Moscow","125167","Russia","RU",{"type":60,"coordinates":61},"Point",[62,63],37.61781,55.75204,{"lat":63,"lon":62},[66],{"name":44,"role":45,"phone":47,"phoneExt":47,"email":48},{"type":68,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR","100609015","phase-2-pet-adapted-first-line-therapy-with-nivolumab-for-advanced-hodgkin-lymphoma-100609015",false,"NCT07209059","PET-Adapted First-Line Therapy With Nivolumab for Advanced Hodgkin Lymphoma","A Single-Center Pilot Study Evaluating the Efficacy and Safety of First-Line Immunochemotherapy With Nivolumab Guided by Interim PET for Stratification and Hazard Minimization in Patients With Advanced Classical Hodgkin Lymphoma (FINISH-HL)","FINISH-HL","Inclusion Criteria:\n\n* Signed written informed consent prior to any study-specific procedures\n* Histologically confirmed classical Hodgkin lymphoma (cHL)\n* Newly diagnosed disease, Ann Arbor stage IIB (bulky), III, or IV\n* At least one measurable lesion ≥15 mm in the longest diameter (by CT)\n* Age between 18 and 60 years (inclusive)\n* ECOG performance status 0-2\n* PET-CT performed at baseline\n* No prior chemotherapy, radiotherapy, or immunotherapy for lymphoma\n* Adequate organ function, including:\n* Serum creatinine ≤ 0.2 mmol\u002FL\n* Absence of severe cardiac, pulmonary, hepatic, or renal dysfunction\n* Ability to comply with the study protocol and scheduled visits\n\nExclusion Criteria:\n\n* Active hepatitis B or C infection\n* Positive test for HIV\n* Pregnancy or breastfeeding\n* Prior or active autoimmune disease requiring systemic therapy\n* Vaccination with a live vaccine within 30 days prior to first nivolumab dose\n* History of non-infectious pneumonitis requiring corticosteroids\n* Prior malignancy (except for adequately treated basal cell carcinoma or cervical carcinoma in situ)\n* Congestive heart failure, unstable angina, recent myocardial infarction, or severe cardiac arrhythmias\n* Severe renal impairment (serum creatinine \\> 0.2 mmol\u002FL), unless lymphoma-related\n* Severe hepatic dysfunction, unless directly related to lymphoma\n* Severe pneumonia with respiratory failure or hypoxemia not corrected within 2-3 days\n* Sepsis or hemodynamic instability\n* Life-threatening bleeding events (e.g., gastrointestinal or cerebral hemorrhage)\n* Cachexia (total serum protein \\\u003C 35 g\u002FL), unless due to lymphoma-related liver damage\n* Decompensated diabetes mellitus\n* Any somatic or psychiatric condition that, in the investigator's judgment, precludes informed consent or study participation","ALL","18 Years","60 Years",{"count":81,"type":82},30,"ESTIMATED","INTERVENTIONAL",[85],"PHASE2","This is a single-center, open-label, phase 2 pilot study evaluating the efficacy and safety of a response-adapted first-line treatment strategy for patients with classical Hodgkin lymphoma (cHL) and unfavorable prognostic factors. The FINISH protocol (First-line Immuno-chemotherapy Navigated by Interim PET for Stratification and Hazard minimization In Hodgkin lymphoma) integrates nivolumab into induction therapy and tailors subsequent treatment based on interim PET-CT response. The study also includes exploratory monitoring of circulating tumor DNA (ctDNA) to investigate its role in early response assessment and residual disease detection.",[88,89,90],"Hodgkin Lymphoma","Hodgkin Disease","Advanced Hodgkin Lymphoma",[92,89,19,93,94,95,96,97,98,99,100,101,102],"Classical Hodgkin Lymphoma","Immunotherapy","First-line treatment","PET-adapted therapy","Checkpoint inhibitors","ctDNA","Response-adapted treatment","EACOPD","AVD","PD-1 blockade","Circulating tumor DNA","2025-09-29",{"date":105,"type":106},"2025-10-06","ACTUAL",{"date":108,"type":106},"2025-07-29",{"date":110,"type":82},"2028-12",{"name":5,"class":6},1]