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Recruiting
NCT05700565
Treatment of Immune-related Adverse Events Refractory to Standard Therapy and Associated Changes in Immunophenotype
Conditions: Immune-related Adverse Event
Sex: All
Enrollment: 50
Sponsor: Lucie Heinzerling
Location: Germany
Summary
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.
Eligibility Criteria
Inclusion Criteria:Subjects must we willing and able to comply with scheduled visits and must have given written informed consent.irAE after immune checkpoint inhibitor therapy (PD-1/PD-L1 or PD-1 + CTLA4 blockade)irAE refractory to therapy with corticosteroids or inability to taper corticosteroids to prednisone equivalent <= 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/kg corticosteroid over 28 days.Exclusion Criteria: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 valuesPregnancyBody weight less than 40 kg.
Source: ClinicalTrials.gov (NCT05700565). StuddyBuddy aggregates publicly available trial information.