[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100426811":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":37,"responsibleParty":55,"collaborators":24,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":24,"enrollmentInfo":67,"targetDuration":24,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":24,"overallStatus":40,"whyStopped":24,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"University of Cologne","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A age 18-60","EXPERIMENTAL","Patients at the age of 18-60 years at enrollment will receive 2 initial doses of 200 mg tislelizumab in 21-day intervals followed by an interim positron emission tomography (PET-2). Following a PET-guided approach, patients with a negative PET-2 (i.e. Deauville score 1-3) according to central review will continue receiving tislelizumab for another 4 doses of 300 mg in 28-day intervals. Patients with a positive PET-2 (i.e. Deauville score \\>3) will receive 4 cycles of combined 300 mg tislelizumab on day 1 and AVD chemotherapy on day 1 and 15 in 28-day cycles (4x T-AVD). For all patients, 30 Gy involved-site radiotherapy (IS-RT) will only be applied in case of PET positivity after completion of (chemo-) immunotherapy.",[13],"Drug: Tislelizumab",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm B Age 60+","Patients above the age of 60 years will be enrolled in a separate, exploratory cohort and receive PET-guided treatment with tislelizumab or T-AVD as described above. However, all patients in the exploratory cohort for older patients will receive consolidating 30 Gy IS-RT.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Tislelizumab","age 18-60: Tislelizumab alone or in combination with AVD (depending on the PET result after 2x Tislelizumab) followed by IS-RT if PET positive resudues after the end of Tis or Tis-AVD age 60+: Tislelizumab alone or in combination with AVD (depending on the PET result after 2x Tislelizumab) followed by IS-RT for all patients",[9,15],null,[26],{"name":27,"affiliation":28,"role":29},"Paul Broeckelmann, Dr.","1st Department of Medicine, Cologne Universit Hospital","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Michael Fuchs","CONTACT","+49221478","88160","ghsg@uk-koeln.de",[38],{"facility":39,"status":40,"city":41,"state":24,"zip":24,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"1st Department of Medicine, Cologne University Hospital","RECRUITING","Cologne","Germany","DE",{"type":45,"coordinates":46},"Point",[47,48],6.95,50.93333,{"lat":48,"lon":47},[51,53],{"name":32,"role":33,"phone":24,"phoneExt":24,"email":52},"GHSG@uk-koeln.de",{"name":54,"role":29,"phone":24,"phoneExt":24,"email":24},"Andreas Engert, MD",{"type":29,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Dr. Paul Broeckelmann","Priv. Doz.","100426811","phase-2-phase-ii-trial-of-individualized-immunotherapy-in-early-stage-unfavorable-classical-hodgkin-lymphoma-100426811",false,"NCT04837859","Phase II Trial of Individualized Immunotherapy in Early-Stage Unfavorable Classical Hodgkin Lymphoma","INDIE","Inclusion Criteria:\n\n* Age 18-60 for the main trial cohort\n* Age ≥ 61 years and eligible for AVD as determined by CIRS-G score and investigator for the exploratory cohort\n* First diagnosis of treatment-naïve cHL\n* Early-stage unfavorable disease (i.e. stage IA, IB and IIA with risk factors a-d, stage IIB with risk factors c-d):\n\n  1. large mediastinal mass\n  2. extranodal lesion(s)\n  3. elevated erythrocyte sedimentation rate\n  4. ≥ 3 nodal areas\n\n     Exclusion Criteria:\n* Presence of nodular-lymphocyte predominant Hodgkin lymphoma, grey-zone lymphoma and\u002For central nervous system involvement of lymphoma","ALL","18 Years",{"count":68,"type":69},120,"ESTIMATED","INTERVENTIONAL",[72],"PHASE2","The aim of the trial is to establish an individualized first-line treatment incorporating checkpoint inhibition for early-stage unfavorable cHL, which is effective and well tolerated.",[75],"Classical Hodgkin Lymphoma","2024-07-25",{"date":78,"type":79},"2024-07-26","ACTUAL",{"date":81,"type":79},"2024-05-24",{"date":83,"type":69},"2028-05",{"name":5,"class":6},1]