CompletedNot Applicable

ECP for Immune-related Adverse Events After Checkpoint Inhibitor Treatment

Germany11 participantsStarted 2021-06-01

Plain-language summary

Preliminary data demonstrate that irAEs induced by immune checkpoint blockade can be successfully treated with ECP (Apostolova et al. NEJM 2020). Therefore this retrospective analysis is launched to validate the finding made with the individual patient in a larger patient cohort. The analysis will include the evaluation of safety of ECP treatment in patients with irAEs and collect data on the efficacy of ECP as a treatment for immune-related adverse events and its effect on tumor progression.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male and female patients aged ≥18 years
. Written informed consent:
. Target population
. Maximum of one additional (second line) therapy after Steroid treatment before ECP starts (e.g. infliximab for colitis)
. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 1 week prior to the start of study drug.
. Women must not be breastfeeding.
. ECOG performance status 0, 1, or 2

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety - treatment-related adverse events (AEs) and severe adverse events (SAEs)

Timeframe: 12 months after end of ECP

Trial details

NCT IDNCT05414552

SponsorUniversity of Freiburg

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-30

View on ClinicalTrials.gov More Immune Related Adverse Events trials