[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100493085":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":23,"centralContacts":28,"locations":36,"responsibleParty":58,"collaborators":10,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":10,"maxAge":10,"enrollmentInfo":69,"targetDuration":10,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"LMU Klinikum","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Steroid-refractory or dependent immune-related adverse events",null,"Immune-related adverse events (irAE) after immune checkpoint inhibitor therapy (PD-1\u002FPD-L1 or PD-1 + CTLA4 blockade) refractory to therapy with corticosteroids or inability to taper corticosteroids to prednisone equivalent \\\u003C= 5mg",[13,14],"Other: Extracorporeal photopheresis","Other: Other immunosuppressive or immunomodulatory drugs",[16,20],{"type":6,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"Extracorporeal photopheresis","ECP consists of the three steps of leukapheresis, photoactivation and reinfusion and has immunomodulatory effects (modulation of dendritic cells, change in cytokine profile, induction of T cell subpopulations). Indications are currently the treatment of Sézary syndrome, Graft-versus-host disease (GvHD), organ transplant rejection and systemic scleroderma.",[9],{"type":6,"name":21,"description":21,"armGroupLabels":22,"otherNames":10},"Other immunosuppressive or immunomodulatory drugs",[9],[24],{"name":25,"affiliation":26,"role":27},"Lucie Heinzerling","Department of Dermatology and Allergy, University Hospital, LMU Munich","PRINCIPAL_INVESTIGATOR",[29,33],{"name":25,"role":30,"phone":31,"phoneExt":10,"email":32},"CONTACT","+49 89 4400 56326","lucie.heinzerling@med.uni-muenchen.de",{"name":34,"role":30,"phone":31,"phoneExt":10,"email":35},"Dirk Tomsitz","dirk.tomsitz@med.uni-muenchen.de",[37],{"facility":38,"status":39,"city":40,"state":10,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"LMU Klinikum Hauttumorzentrum","RECRUITING","Munich","80337","Germany","DE",{"type":45,"coordinates":46},"Point",[47,48],11.57549,48.13743,{"lat":48,"lon":47},[51,54,57],{"name":52,"role":30,"phone":53,"phoneExt":10,"email":32},"Lucie Heinzerling, Prof. Dr.","+49 89 4400 56052",{"name":55,"role":30,"phone":56,"phoneExt":10,"email":35},"Dirk Tomsitz, Dr.","+49 1525 4849311",{"name":52,"role":27,"phone":10,"phoneExt":10,"email":10},{"type":59,"investigatorFullName":25,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Prof. Dr. (MPH)","100493085","treatment-of-immune-related-adverse-events-refractory-to-standard-therapy-and-associated-changes-in-immunophenotype-100493085",false,"NCT05700565","Treatment of Immune-related Adverse Events Refractory to Standard Therapy and Associated Changes in Immunophenotype","PRIA","Inclusion Criteria:\n\n1. Subjects must we willing and able to comply with scheduled visits and must have given written informed consent.\n2. irAE after immune checkpoint inhibitor therapy (PD-1\u002FPD-L1 or PD-1 + CTLA4 blockade)\n3. irAE refractory to therapy with corticosteroids or inability to taper corticosteroids to prednisone equivalent \\\u003C= 5mg. An irAE is defined as refractory if corticosteroids do not improve symptoms within 72 hours. The inability to taper corticosteroids is defined as relapse on standard tapering of 1 mg\u002Fkg corticosteroid over 28 days.\n\nExclusion Criteria:\n\n1. Contraindications for the treatment with ECP including a known sensitivity to psoralen compounds such as 8-MOP, comorbidities that may result in photosensitivity, aphakia, history of heparin-induced thrombocytopenia, unsatisfactory cardio-circulatory function, low hematocrit values\n2. Pregnancy\n3. Body weight less than 40 kg.","ALL",{"count":70,"type":71},50,"ESTIMATED","OBSERVATIONAL","This study is an open, monocentric study. It includes patients with irAE refractory to standard therapy or patients where corticosteroids cannot be tapered. Patients will either be treated with ECP or second line immunosuppressive therapy according to investigator's choice. Patients will be followed for 24 weeks after first treatment.",[75],"Immune-related Adverse Event",[77,78],"Steroid-refractory","Steroid-dependent","2024-03-13",{"date":81,"type":82},"2024-03-15","ACTUAL",{"date":84,"type":82},"2022-01-01",{"date":86,"type":71},"2027-01-01",{"name":25,"class":6},1]