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RECRUITING
NCT05700565

Treatment of Immune-related Adverse Events Refractory to Standard Therapy and Associated Changes in Immunophenotype

Sponsor: Lucie Heinzerling

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2022-01-01

Completion Date

2027-01-01

Last Updated

2024-03-15

Healthy Volunteers

Not specified

Interventions

OTHER

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.

OTHER

Other immunosuppressive or immunomodulatory drugs

Other immunosuppressive or immunomodulatory drugs

Locations (1)

LMU Klinikum Hauttumorzentrum

Munich, Germany