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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.
At inclusion patient history including type of tumor and immunotherapy will be obtained.
At all visits symptoms, changes in concomitant medication, a medical assessment and laboratory investigations will be performed. Blood sampling for safety analysis and for investigating the immunophenotype will be performed at baseline, week 1, 4, 8 and 12.
Laboratory values assessed include:
Additionally, patients will assess their symptoms and their quality of life by a self-administered questionnaire at baseline and week 4, 8 and 12. Quality of life will be assessed by EORTC QLQ-C30. All irAE will be graded according to CTCAE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Steroid-refractory or dependent immune-related adverse events | Immune-related adverse events (irAE) after immune checkpoint inhibitor therapy (PD-1/PD-L1 or PD-1 + CTLA4 blockade) refractory to therapy with corticosteroids or inability to taper corticosteroids to prednisone equivalent <= 5mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal photopheresis | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunophenotype | Characterisation of peripheral mononuclear blood cells | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Developement of grade of irAE | irAE symptoms graded according to CTCAE v5.0 | 12 weeks |
| Patient quality of life | Quality of life assessed by EORTC QLQ-C30 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with irAE after immune checkpoint inhibitor therapy (PD-1/PD-L1 or PD-1 + CTLA4 blockade) 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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucie Heinzerling | Contact | +49 89 4400 56326 | lucie.heinzerling@med.uni-muenchen.de | |
| Dirk Tomsitz | Contact | +49 89 4400 56326 | dirk.tomsitz@med.uni-muenchen.de |
| Name | Affiliation | Role |
|---|---|---|
| Lucie Heinzerling | Department of Dermatology and Allergy, University Hospital, LMU Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LMU Klinikum Hauttumorzentrum | Recruiting | Munich | 80337 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42285609 | Derived | Wein L, Ertl C, Ruf T, Morak M, Wang Y, Schmitt C, Garza Vazquez X, Glatzel V, David-Rus R, Mitwalli M, Srour J, Schopf P, Tomsitz D, French LE, Heinzerling L. Extracorporeal photopheresis versus systemic immunosuppression for treatment of immune-related adverse events: clinical outcomes from the prospective two-arm PRIA study. J Immunother Cancer. 2026 Jun 12;14(6):e015185. doi: 10.1136/jitc-2026-015185. | |
| 39383612 |
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Blood (Serum, EDTA)
|
| Other immunosuppressive or immunomodulatory drugs | Other | Other immunosuppressive or immunomodulatory drugs |
|
| 12 weeks |
| Derived |
| Ertl C, Ruf T, Hammann L, Piseddu I, Wang Y, Schmitt C, Garza Vazquez X, Kabakci C, Bonczkowitz P, de Toni EN, David-Rus R, Srour J, Tomsitz D, French LE, Heinzerling L. Extracorporeal photopheresis vs. systemic immunosuppression for immune-related adverse events: Interim analysis of a prospective two-arm study. Eur J Cancer. 2024 Nov;212:115049. doi: 10.1016/j.ejca.2024.115049. Epub 2024 Sep 27. |
| ID | Term |
|---|---|
| D017893 | Photopheresis |
| D000091369 | Immunomodulating Agents |
| ID | Term |
|---|---|
| D011701 | PUVA Therapy |
| D014467 | Ultraviolet Therapy |
| D010789 | Phototherapy |
| D013812 | Therapeutics |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
| D007155 | Immunologic Factors |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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