[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100426872":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":33,"responsibleParty":51,"collaborators":20,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":20,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":20,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"University of Cologne","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pembrolizumab plus Chemotherapy","EXPERIMENTAL","All patients will receive 1 dose of 200 mg pembrolizumab IV as single agent upfront, followed by 2 cycles of IV P-ICE (pembrolizumab, ifosfamide, carboplatin, etoposide) and a PET\u002FCT-based restaging. Following a PET-guided treatment strategy, patients will then receive either another 2 cycles of IV P-ICE in case of a negative PET (i.e., Deauville score 1-3), or 2 to 4 cycles of IV P-DHAP (pembrolizumab, dexamethasone, cytarabine, cisplatin) in case of a positive PET (i.e., Deauville score \\> 3). After completion of treatment with P-ICE or P-DHAP, respectively, patients will receive a consolidation therapy with pembrolizumab for another 6 cycles. In case of non-CR after at least 4 cycles of combination therapy (4x P-ICE or 2x P-ICE + 2x P-DHAP), physicians may decide to go for HDCT or an alternative standard of care treatment option.",[13],"Drug: Pembrolizumab plus Chemotherapy (ICE or DHAP)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Pembrolizumab plus Chemotherapy (ICE or DHAP)","Pembrolizumab (200mg) alone or in combination with ICE (or DHAP in case of PET positive findings after P-ICE) will be admistered. 6 additional courses of pembrolizumab will be administered after the completion P-ICE or P-DHAP",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Andreas Engert, Prof.","1st Department of Medicine, Cologne Universit Hospital","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Michael Fuchs","CONTACT","+49221478","88160","ghsg@uk-koeln.de",[34],{"facility":35,"status":36,"city":37,"state":20,"zip":20,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"1st Department of Medicine, Cologne University Hospital","RECRUITING","Cologne","Germany","DE",{"type":41,"coordinates":42},"Point",[43,44],6.95,50.93333,{"lat":44,"lon":43},[47,49],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":48},"GHSG@uk-koeln.de",{"name":50,"role":25,"phone":20,"phoneExt":20,"email":20},"Peter Borchmann, MD",{"type":25,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Prof. Dr. Peter Borchmann","Prof.","100426872","phase-2-pembrolizumab-in-combination-with-salvage-chemotherapy-for-first-relapsed-or-refractory-classical-hodgkin-lymphoma-100426872",false,"NCT04838652","Pembrolizumab in Combination With Salvage Chemotherapy for First-relapsed or Refractory Classical Hodgkin Lymphoma","Phase II Trial of Pembrolizumab in Combination With Salvage Chemotherapy for First-relapsed or Refractory Classical Hodgkin Lymphoma","Pembro-CORE","Inclusion Criteria:\n\n* Histologically confirmed first relapse of cHL or primary refractory cHL\n\nExclusion Criteria:\n\n* Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma","ALL","18 Years","65 Years",{"count":66,"type":67},29,"ESTIMATED","INTERVENTIONAL",[70],"PHASE2","The aim of this trial is to develop an effective and well-tolerated regimen for treatment of r\u002Fr cHL by introducing the anti-PD-1 antibody pembrolizumab and adding it to well-established chemotherapy regimens (ICE, DHAP). Synergistic effects of conventional agents with checkpoint inhibition may facilitate a highly effective therapy with limited toxicity, which might eventually substitute the very toxic high-dose chemotherapy (HDCT).",[73],"Classical Hodgkin Lymphoma","2024-08-21",{"date":76,"type":77},"2024-08-23","ACTUAL",{"date":79,"type":77},"2024-03-05",{"date":81,"type":67},"2028-05",{"name":5,"class":6},1]