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

NCT05700565 | Recruiting

• 1 other identifier: LMUKlinikum
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Immune-related Adverse Event

Keywords

Steroid-refractory; Steroid-dependent

Outcome Measures

Primary Outcomes (1)

• Immunophenotype

  Characterisation of peripheral mononuclear blood cells

  12 weeks

Secondary Outcomes (2)

• Developement of grade of irAE

  12 weeks

• Patient quality of life

  12 weeks

Study Arms (1)

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

Other: Extracorporeal photopheresis; Other: Other immunosuppressive or immunomodulatory drugs

Interventions

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.

Steroid-refractory or dependent immune-related adverse events

Other immunosuppressive or immunomodulatory drugs OTHER

Other immunosuppressive or immunomodulatory drugs

Steroid-refractory or dependent immune-related adverse events

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• Pregnancy
• Body weight less than 40 kg.

Sponsors & Collaborators

• Lucie Heinzerling: lead

Study Sites (1)

LMU Klinikum Hauttumorzentrum

Munich, 80337, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 39383612 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood (Serum, EDTA)

MeSH Terms

Interventions

Photopheresis; Immunomodulating Agents

Intervention Hierarchy (Ancestors)

PUVA Therapy; Ultraviolet Therapy; Phototherapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative; Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Lucie Heinzerling

  Department of Dermatology and Allergy, University Hospital, LMU Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. (MPH)

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: January 26, 2023
• Study Start: January 1, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

DE (1)