Evaluating extracorporeal photopheresis for subclinical lung transplant rejection
The Use of Extracorporeal Photopheresis as Immunomodulatory Therapy of Subclinical Antibody-mediated Rejection After Lung Transplantation: a Prospective RCT
This study is testing if a light-based treatment called extracorporeal photopheresis can help lung transplant patients who have early signs of rejection feel better and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Drugs / interventions | Alemtuzumab |
| Locations | 7 sites (Vienna and 6 other locations) |
| Trial ID | NCT06112951 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of extracorporeal photopheresis (ECP) in patients with subclinical antibody-mediated rejection following lung transplantation. Participants will be randomized into two groups, with one receiving ECP treatment and the other serving as a control. The study will measure the reduction in donor-specific antibodies and evaluate various clinical outcomes, including acute cellular rejection, chronic lung allograft dysfunction, and overall survival. The trial seeks to provide insights into the immunological effects of ECP and its potential as a safe treatment option for this patient population.
Who should consider this trial
Good fit: Ideal candidates are patients who have undergone bilateral lung transplantation and have persistent donor-specific antibodies with a mean fluorescence intensity greater than 1000.
Not a fit: Patients who have signs of allograft dysfunction or are more than 12 months post-transplant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for lung transplant recipients experiencing subclinical rejection.
How similar studies have performed: Previous studies have shown promise for extracorporeal photopheresis in treating antibody-mediated rejection, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Bilateral lung transplantation * dnDSAs \> 3 months with a MFI \> 1000 * No signs of allograft dysfunction * Alemtuzumab induction therapy Exclusion Criteria: * Inclusion in other studies * Retransplantation * Multi-organ transplantation * \> 12 months after transplantation
Where this trial is running
Vienna and 6 other locations
- Medical University of Vienna — Vienna, Austria (Recruiting)
- UZ Leuven — Leuven, Belgium (Not_yet_recruiting)
- University Hospital Center Zagreb — Zagreb, Croatia (Not_yet_recruiting)
- Copenhagen University Hospital, Rigshospitalet — Copenhagen, Denmark (Not_yet_recruiting)
- Hôpital Foch — Suresnes, France (Not_yet_recruiting)
- Policlinico San Matteo Pavia Fondazione IRCCS — Pavia, Italy (Not_yet_recruiting)
- University Medical Centre Ljubljana — Ljubljana, Slovenia (Not_yet_recruiting)
Study contacts
- Principal investigator: Alberto Benazzo, MD PhD — Medical University of Vienna
- Study coordinator: Caroline Hillebrand, MD
- Email: caroline.hillebrand@outlook.com
- Phone: +4314040069470
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.