Actively Recruiting
Treatment of Immune-related Adverse Events Refractory to Standard Therapy and Associated Changes in Immunophenotype
Led by Lucie Heinzerling · Updated on 2024-03-15
50
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment of Immune-related Adverse Events Refractory to Standard Therapy and Associated Changes in Immunophenotype
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to comply with scheduled visits and have given written informed consent
- Have immune-related adverse events after immune checkpoint inhibitor therapy (PD-1/PD-L1 or PD-1 + CTLA4 blockade)
- Have immune-related adverse events refractory to corticosteroids or inability to taper corticosteroids to prednisone equivalent of 5 mg or less
- Refractory defined as no symptom improvement within 72 hours of corticosteroids
- Inability to taper corticosteroids defined as relapse during standard tapering of 1 mg/kg over 28 days
You will not qualify if you...
- Contraindications to extracorporeal photopheresis including sensitivity to psoralen compounds, photosensitivity conditions, aphakia, history of heparin-induced thrombocytopenia, poor cardio-circulatory function, or low hematocrit
- Pregnancy
- Body weight less than 40 kg
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
LMU Klinikum Hauttumorzentrum
Munich, Germany, 80337
Actively Recruiting
Research Team
L
Lucie Heinzerling
CONTACT
D
Dirk Tomsitz
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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