- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06112951
A Prospective Randomized Trial of ECP in Subclinical AMR (EXPORT-DSA)
The Use of Extracorporeal Photopheresis as Immunomodulatory Therapy of Subclinical Antibody-mediated Rejection After Lung Transplantation: a Prospective RCT
The goal of this clinical trial is to evaluate the therapeutic effect of extracorporeal photopheresis in subclinical antibody-mediated rejection after lung transplantation.The main questions it aims to answer are:
- Does ECP therapy result in a significant reduction in MFI (Mean Fluorescence Intensity) from the baseline MFI in clinically stable patients with persistent (>6 months) dnDSAs (MFI>1000)?
- What is the impact of ECP therapy on the following outcomes in these patients: ACR, clinical AMR, CLAD, infections, drop-out rate, survival, adverse events?
Participants will be randomized into two groups. Each group will include 40 patients. The control group will be observed and no active treatment will be administered. The treatment group will receive extracorporeal photopheresis. First, a two-day treatment cycle will be performed once every second week for the first two months. Then, a two-day treatment cycle will be performed once a month for 6 months.
Researchers will compare the two groups regarding: MFI value, development of ACR, clinical AMR, CLAD, infections, survival, adverse events, immunophenotyping, miRNA expression profiling, cytokine expression, gene expression signature of PBMCs and proteomic characterization.
Study Overview
Status
Intervention / Treatment
Detailed Description
Donor-specific antibodies (DSA) and antibody-mediated rejection have gained significant attention recently due to their serious consequences, but there are limited effective treatments for persistent DSAs in patients without graft dysfunction due to their associated severe side effects. Our center demonstrated that extracorporeal photopheresis (ECP) can potentially reduce the mean fluorescence intensity of dnDSAs in recipients with antibody-mediated rejection (AMR), suggesting it as a safe option for treating subclinical AMR with dnDSAs and inducing tolerogenic immunomodulation in this complex population.
The hypothesis underlying the proposed randomized controlled trial is that ECP might have the potential to reduce the burden of de novo donor-specific antibodies after lung transplantation, by modulating host humoral alloresponse and promoting tolerance, without provoking side effects.
Our primary objective is to evaluate the therapeutic effect of ECP in terms of reduction of dnDSAs titer in clinically stable patients with persistent (>6 months) dnDSAs (MFI>1000). As secondary objective, we intend to assess the therapeutic effect of ECP on incidence of clinical AMR, ACR, CLAD, survival and occurrence of infectious complications as well as the rate of adverse effects. Our experimental objectives are to provide an in-depth analysis of the immunological effects of ECP.
80 patients with persistent dnDSAs (> 3 months) with a MFI > 1000 will be randomized into two groups. Each group will include 40 patients. Patients will be stratified according to the presence of HLA-DQ. The control group will be observed and no active treatment will be administered. This is our standard of care in the studied clinical situation. Treatment group will receive extracorporeal photopheresis. First, a two-day treatment cycle will be performed once every second week for the first two months. Then, a two-day treatment cycle will be performed once a month for 6 months. To elucidate the specific mechanisms of ECP in modulating humoral alloresponse, a series of studies are planned: 1) flow cytometric immunophenotyping, 2) miRNA expression profiling, 3) cytokine expression, 4) gene expression signature of PBMCs, 5) proteomic characterization.
The proposed study aims to address this clinical need by investigating the effects of a safe therapeutic modality such as ECP. This study may have a dual benefit: first, it may reduce the burden of dnDSAs in lung transplant recipients, thereby reducing the incidence of antibody-mediated rejection, and second, it may promote host tolerance to the graft. In addition, we will investigate the immunomodulatory mechanisms of ECP in the context of humoral allogeneic response, which has not been previously investigated.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Caroline Hillebrand, MD
- Phone Number: +436641107970 +4314040069470
- Email: caroline.hillebrand@outlook.com
Study Contact Backup
- Name: Alberto Benazzo, MD PhD
- Phone Number: +4314040052600
- Email: alberto.benazzo@meduniwien.ac.at
Study Locations
-
-
-
Vienna, Austria, 1090
- Recruiting
- Medical University of Vienna
-
Contact:
- Alberto Benazzo, MD PhD
- Phone Number: 00436766093043
- Email: alberto.benazzo@meduniwien.ac.at
-
Principal Investigator:
- Alberto Benazzo, MD PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Group
Treatment group will receive extracorporeal photopheresis.
First, a two-day treatment cycle will be performed once every second week for the first two months.
Then, a two-day treatment cycle will be performed once a month for 6 months.
|
Patients randomized into the interventional group will receive ECP. ECP will be started within one week after randomization.
Initially a two-day treatment cycle will be performed once every second week for the first two months.
Then, a two-day treatment cycle will be performed once a month for 6 months.
|
No Intervention: Control Group
Control group will be observed and no active treatment will be administered.
This is our standard of care in the studied clinical situation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction of dnDSA titer from baseline MFI
Time Frame: 6 months
|
Difference of MFI values at the start and at the end of the six month period
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of clinical AMR, ACR, CLAD, survival, infectious complications, adverse effects
Time Frame: 6 months
|
Incidence of clinical AMR, ACR, CLAD, survival, infectious complications, adverse effects
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alberto Benazzo, MD PhD, Medical University of Vienna
Publications and helpful links
General Publications
- Girnita AL, Duquesnoy R, Yousem SA, Iacono AT, Corcoran TE, Buzoianu M, Johnson B, Spichty KJ, Dauber JH, Burckart G, Griffith BP, McCurry KR, Zeevi A. HLA-specific antibodies are risk factors for lymphocytic bronchiolitis and chronic lung allograft dysfunction. Am J Transplant. 2005 Jan;5(1):131-8. doi: 10.1111/j.1600-6143.2004.00650.x.
- Morrell MR, Despotis GJ, Lublin DM, Patterson GA, Trulock EP, Hachem RR. The efficacy of photopheresis for bronchiolitis obliterans syndrome after lung transplantation. J Heart Lung Transplant. 2010 Apr;29(4):424-31. doi: 10.1016/j.healun.2009.08.029. Epub 2009 Oct 22.
- Levine DJ, Glanville AR, Aboyoun C, Belperio J, Benden C, Berry GJ, Hachem R, Hayes D Jr, Neil D, Reinsmoen NL, Snyder LD, Sweet S, Tyan D, Verleden G, Westall G, Yusen RD, Zamora M, Zeevi A. Antibody-mediated rejection of the lung: A consensus report of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2016 Apr;35(4):397-406. doi: 10.1016/j.healun.2016.01.1223. Epub 2016 Feb 10.
- Rose EA, Barr ML, Xu H, Pepino P, Murphy MP, McGovern MA, Ratner AJ, Watkins JF, Marboe CC, Berger CL. Photochemotherapy in human heart transplant recipients at high risk for fatal rejection. J Heart Lung Transplant. 1992 Jul-Aug;11(4 Pt 1):746-50.
- Barr ML, Baker CJ, Schenkel FA, McLaughlin SN, Stouch BC, Starnes VA, Rose EA. Prophylactic photopheresis and chronic rejection: effects on graft intimal hyperplasia in cardiac transplantation. Clin Transplant. 2000 Apr;14(2):162-6. doi: 10.1034/j.1399-0012.2000.140211.x.
- Jaksch P, Scheed A, Keplinger M, Ernst MB, Dani T, Just U, Nahavandi H, Klepetko W, Knobler R. A prospective interventional study on the use of extracorporeal photopheresis in patients with bronchiolitis obliterans syndrome after lung transplantation. J Heart Lung Transplant. 2012 Sep;31(9):950-7. doi: 10.1016/j.healun.2012.05.002.
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- Benazzo A, Auner S, Boehm PM, Morscher A, Schwarz S, Vidmar B, Dzubur F, Schweiger T, Hoda AM, Moser B, Matilla JR, Murakozy G, Lang G, Taghavi S, Klepetko W, Hoetzenecker K, Jaksch P. Outcomes with alemtuzumab induction therapy in lung transplantation: a comprehensive large-scale single-center analysis. Transpl Int. 2021 Dec;34(12):2633-2643. doi: 10.1111/tri.14153. Epub 2021 Nov 16.
- Iasella CJ, Ensor CR, Marrari M, Mangiola M, Xu Q, Nolley E, Moore CA, Morrell MR, Pilewski JM, Sanchez PG, McDyer JF, Zeevi A. Donor-specific antibody characteristics, including persistence and complement-binding capacity, increase risk for chronic lung allograft dysfunction. J Heart Lung Transplant. 2020 Dec;39(12):1417-1425. doi: 10.1016/j.healun.2020.09.003. Epub 2020 Sep 10.
- Benazzo A, Worel N, Schwarz S, Just U, Nechay A, Lambers C, Bohmig G, Fischer G, Koren D, Murakozy G, Knobler R, Klepetko W, Hoetzenecker K, Jaksch P. Outcome of Extracorporeal Photopheresis as an Add-On Therapy for Antibody-Mediated Rejection in Lung Transplant Recipients. Transfus Med Hemother. 2020 Jun;47(3):205-213. doi: 10.1159/000508170. Epub 2020 May 5.
- Gasparro FP, Felli A, Schmitt IM. Psoralen photobiology: the relationship between DNA damage, chromatin structure, transcription, and immunogenic effects. Recent Results Cancer Res. 1997;143:101-27. doi: 10.1007/978-3-642-60393-8_8. No abstract available.
- Kurts C, Kosaka H, Carbone FR, Miller JF, Heath WR. Class I-restricted cross-presentation of exogenous self-antigens leads to deletion of autoreactive CD8(+) T cells. J Exp Med. 1997 Jul 21;186(2):239-45. doi: 10.1084/jem.186.2.239.
- Maeda A, Schwarz A, Bullinger A, Morita A, Peritt D, Schwarz T. Experimental extracorporeal photopheresis inhibits the sensitization and effector phases of contact hypersensitivity via two mechanisms: generation of IL-10 and induction of regulatory T cells. J Immunol. 2008 Nov 1;181(9):5956-62. doi: 10.4049/jimmunol.181.9.5956.
- Maeda A, Schwarz A, Kernebeck K, Gross N, Aragane Y, Peritt D, Schwarz T. Intravenous infusion of syngeneic apoptotic cells by photopheresis induces antigen-specific regulatory T cells. J Immunol. 2005 May 15;174(10):5968-76. doi: 10.4049/jimmunol.174.10.5968.
- Edelson RL. Mechanistic insights into extracorporeal photochemotherapy: efficient induction of monocyte-to-dendritic cell maturation. Transfus Apher Sci. 2014 Jun;50(3):322-9. doi: 10.1016/j.transci.2013.07.031. Epub 2013 Aug 8.
- Knobler R. Extracorporeal photochemotherapy--present and future. Vox Sang. 2000;78 Suppl 2:197-201.
- Teruel Montoya R, López-Godino O, Garcia-Barbera N, et al. Identification of Circulating microRNA Signatures As Potential Noninvasive Biomarkers for Prediction to Response to Extracorporeal Photoapheresis in Patients with Graft Versus Host Disease. Blood 2019;134:4466-.
- Bozzini S, Del Fante C, Morosini M, Berezhinskiy HO, Auner S, Cattaneo E, Della Zoppa M, Pandolfi L, Cacciatore R, Perotti C, Hoetzenecker K, Jaksch P, Benazzo A, Meloni F. Mechanisms of Action of Extracorporeal Photopheresis in the Control of Bronchiolitis Obliterans Syndrome (BOS): Involvement of Circulating miRNAs. Cells. 2022 Mar 25;11(7):1117. doi: 10.3390/cells11071117.
- Greer M, Liu B, Magnusson JM, Fuehner T, Schmidt BMW, Deluca D, Falk C, Ius F, Welte T. Assessing treatment outcomes in CLAD: The Hannover-extracorporeal photopheresis model. J Heart Lung Transplant. 2023 Feb;42(2):209-217. doi: 10.1016/j.healun.2022.09.022. Epub 2022 Oct 5.
- Zeevi A, Lunz J, Feingold B, Shullo M, Bermudez C, Teuteberg J, Webber S. Persistent strong anti-HLA antibody at high titer is complement binding and associated with increased risk of antibody-mediated rejection in heart transplant recipients. J Heart Lung Transplant. 2013 Jan;32(1):98-105. doi: 10.1016/j.healun.2012.09.021. Epub 2012 Nov 9.
- Sundaresan S, Mohanakumar T, Smith MA, Trulock EP, Lynch J, Phelan D, Cooper JD, Patterson GA. HLA-A locus mismatches and development of antibodies to HLA after lung transplantation correlate with the development of bronchiolitis obliterans syndrome. Transplantation. 1998 Mar 15;65(5):648-53. doi: 10.1097/00007890-199803150-00008.
- Morrell MR, Patterson GA, Trulock EP, Hachem RR. Acute antibody-mediated rejection after lung transplantation. J Heart Lung Transplant. 2009 Jan;28(1):96-100. doi: 10.1016/j.healun.2008.09.013. Epub 2008 Dec 4.
- Roux A, Thomas KA, Sage E, Suberbielle-Boissel C, Beaumont-Azuar L, Parquin F, Le Guen M, Harre N, Hamid AM, Reed EF. Donor-specific HLA antibody-mediated complement activation is a significant indicator of antibody-mediated rejection and poor long-term graft outcome during lung transplantation: a single center cohort study. Transpl Int. 2018 Jul;31(7):761-772. doi: 10.1111/tri.13149. Epub 2018 Apr 22.
- Hachem RR, Tiriveedhi V, Patterson GA, Aloush A, Trulock EP, Mohanakumar T. Antibodies to K-alpha 1 tubulin and collagen V are associated with chronic rejection after lung transplantation. Am J Transplant. 2012 Aug;12(8):2164-71. doi: 10.1111/j.1600-6143.2012.04079.x. Epub 2012 May 8.
- Witt CA, Gaut JP, Yusen RD, Byers DE, Iuppa JA, Bennett Bain K, Alexander Patterson G, Mohanakumar T, Trulock EP, Hachem RR. Acute antibody-mediated rejection after lung transplantation. J Heart Lung Transplant. 2013 Oct;32(10):1034-40. doi: 10.1016/j.healun.2013.07.004. Epub 2013 Aug 13.
- Tinckam KJ, Keshavjee S, Chaparro C, Barth D, Azad S, Binnie M, Chow CW, de Perrot M, Pierre AF, Waddell TK, Yasufuku K, Cypel M, Singer LG. Survival in sensitized lung transplant recipients with perioperative desensitization. Am J Transplant. 2015 Feb;15(2):417-26. doi: 10.1111/ajt.13076.
- Hachem RR, Yusen RD, Meyers BF, Aloush AA, Mohanakumar T, Patterson GA, Trulock EP. Anti-human leukocyte antigen antibodies and preemptive antibody-directed therapy after lung transplantation. J Heart Lung Transplant. 2010 Sep;29(9):973-80. doi: 10.1016/j.healun.2010.05.006. Epub 2010 Jun 16.
- Keller M, Yang S, Ponor L, Bon A, Cochrane A, Philogene M, Bush E, Shah P, Mathew J, Brown AW, Kong H, Charya A, Luikart H, Nathan SD, Khush KK, Jang M, Agbor-Enoh S. Preemptive treatment of de novo donor-specific antibodies in lung transplant patients reduces subsequent risk of chronic lung allograft dysfunction or death. Am J Transplant. 2023 Apr;23(4):559-564. doi: 10.1016/j.ajt.2022.12.019. Epub 2023 Jan 19.
- Wang L, Ni M, Huckelhoven-Krauss A, Sellner L, Hoffmann JM, Neuber B, Luft T, Hegenbart U, Schonland S, Kleist C, Sill M, Chen BA, Wuchter P, Eckstein V, Kruger W, Hilgendorf I, Yerushalmi R, Nagler A, Muller-Tidow C, Ho AD, Dreger P, Schmitt M, Schmitt A. Modulation of B Cells and Homing Marker on NK Cells Through Extracorporeal Photopheresis in Patients With Steroid-Refractory/Resistant Graft-Vs.-Host Disease Without Hampering Anti-viral/Anti-leukemic Effects. Front Immunol. 2018 Oct 8;9:2207. doi: 10.3389/fimmu.2018.02207. eCollection 2018.
- Bladon J, Taylor P. Extracorporeal photopheresis reduces the number of mononuclear cells that produce pro-inflammatory cytokines, when tested ex-vivo. J Clin Apher. 2002;17(4):177-82. doi: 10.1002/jca.10039.
- Li W, Gauthier JM, Higashikubo R, Hsiao HM, Tanaka S, Vuong L, Ritter JH, Tong AY, Wong BW, Hachem RR, Puri V, Bharat A, Krupnick AS, Hsieh CS, Baldwin WM 3rd, Kelly FL, Palmer SM, Gelman AE, Kreisel D. Bronchus-associated lymphoid tissue-resident Foxp3+ T lymphocytes prevent antibody-mediated lung rejection. J Clin Invest. 2019 Feb 1;129(2):556-568. doi: 10.1172/JCI122083. Epub 2018 Dec 18.
- Luo Y, Luo F, Zhang K, Wang S, Zhang H, Yang X, Shang W, Wang J, Wang Z, Pang X, Feng Y, Liu L, Xie H, Feng G, Li J. Elevated Circulating IL-10 Producing Breg, but Not Regulatory B Cell Levels, Restrain Antibody-Mediated Rejection After Kidney Transplantation. Front Immunol. 2021 Jan 28;11:627496. doi: 10.3389/fimmu.2020.627496. eCollection 2020.
- Budde H, Berntsch U, Riggert J, Legler TJ. In vitro effects of different 8-methoxypsoralen treatment protocols for extracorporeal photopheresis on mononuclear cells. Cent Eur J Immunol. 2017;42(1):1-9. doi: 10.5114/ceji.2017.67312. Epub 2017 May 8.
- Baskaran G, Tiriveedhi V, Ramachandran S, Aloush A, Grossman B, Hachem R, Mohanakumar T. Efficacy of extracorporeal photopheresis in clearance of antibodies to donor-specific and lung-specific antigens in lung transplant recipients. J Heart Lung Transplant. 2014 Sep;33(9):950-6. doi: 10.1016/j.healun.2014.04.020. Epub 2014 May 9.
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1578/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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