Immune-related Adverse Event Clinical Trial
— PRIAOfficial title:
Treatment of Immune-related Adverse Events Refractory to Standard Therapy and Associated Changes in Immunophenotype
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | January 1, 2027 |
Est. primary completion date | January 1, 2027 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Subjects must we willing and able to comply with scheduled visits and must have given written informed consent. 2. irAE after immune checkpoint inhibitor therapy (PD-1/PD-L1 or PD-1 + CTLA4 blockade) 3. 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: 1. 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 2. Pregnancy 3. Body weight less than 40 kg. |
Country | Name | City | State |
---|---|---|---|
Germany | LMU Klinikum Hauttumorzentrum | Munich |
Lead Sponsor | Collaborator |
---|---|
Lucie Heinzerling |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Immunophenotype | Characterisation of peripheral mononuclear blood cells | 12 weeks | |
Secondary | Developement of grade of irAE | irAE symptoms graded according to CTCAE v5.0 | 12 weeks | |
Secondary | Patient quality of life | Quality of life assessed by EORTC QLQ-C30 | 12 weeks |
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