Treatment Of Steroid-Refractory Acute Graft-versus-host Disease With Mesenchymal Stromal Cells Versus Best Available Therapy
Condition(s) studied
Investigational drug(s) / intervention(s)
MC0518: MC0518 will be intravenously infused immediately after thawing.
BAT: BAT including MMF, ECP, ATG, everolimus, and RUX will be administered based on Investigator's decision.
Study summary
The primary purpose of this trial is to demonstrate the superiority of MC0518 compared to the first used best available therapy (BAT) with respect to overall response rate (ORR) at Day 28 and/or overall survival (OS) until Visit Month 24 in adult and adolescent subjects with steroid-refractory acute graft-versus-host disease (SR-aGvHD).
Eligibility
Primary outcome measure(s)
- Overall Response (OR) — Day 28
OR is defined as complete response (CR) or partial response (PR) at Day 28 relative to aGvHD status at baseline. CR is defined as resolution of aGvHD in all involved organs. PR is defined as improvement in 1 stage in 1 or more organs involved with aGvHD symptoms without progression in others. Number of participants with OR will be reported. - Overall Survival — Up to Month 24
Overall survival is defined as the time from randomization to the date of death due to any cause.
Trial sites (42)
| Facility | City | Region | Status |
|---|---|---|---|
| Centre Hospitalier Universitaire (CHU) Amiens-Picardie - Hopital Sud | Amiens | France | Recruiting |
| CHU Jean Minjoz | Besançon | France | Recruiting |
| Hopital Michallon | Grenoble | France | Recruiting |
| CHRU Lille- Hopital Claude Huriez | Lille | France | Recruiting |
| CHU de Nantes - Hotel Dieu | Nantes | France | Recruiting |
| CHU de Nice Hopital Archet 1 | Nice | France | Recruiting |
| Centre Hospitalier Lyon Sud Pavillon Marcel Berard 1G | Pierre-Bénite | France | Recruiting |
| Centre Hospitalier Universitaire CHU de Toulouse | Toulouse | France | Recruiting |
| Hopitaux De Brabois | Vandœuvre-lès-Nancy | France | Recruiting |
| Klinikum rechts der Isar | Munich | Bavaria | Recruiting |
| Universitaetsklinikum Wuerzburg - Medizinische Klinik und Poliklinik II - Zentrum fuer Allogene Blutstammzelltransplantation | Würzburg | Bavaria | Recruiting |
| Klinikum der Johann Wolfgang Goethe-Universitaet - Frankfurt am Main | Frankfurt am Main | Hesse | Recruiting |
| Medizinische Hochschule Hannover | Hanover | Lower Saxony | Recruiting |
| Uniklinik Koeln | Cologne | North Rhine-Westphalia | Active Not Recruiting |
| Universitaetsklinikum Essen - Klinik fuer Knochenmarktransplantation (KMT) | Essen | North Rhine-Westphalia | Recruiting |
| Universitaetsklinikum Muenster | Münster | North Rhine-Westphalia | Recruiting |
| Universitaetsklinikum Carl Gustav Carus Dresden | Dresden | Saxony | Recruiting |
| Universitaetsklinikum Leipzig, Selbststaendige Abteilung fur Haematologie und Internistische Onkologie | Leipzig | Saxony | Recruiting |
| Universitaetsklinikum Jena Klinik fuer Innere Medizin II, Haematologie und Onkologie | Jena | Thuringia | Recruiting |
| Universitaetsklinikum Jena - Klinik fuer Paediatrische Haematologie und Onkologie | Jena | Thuringia | Terminated |
| Charite Universitaetsmedizin | Berlin | Germany | Withdrawn |
| Helios Klinikum Berlin-Buch | Berlin | Germany | Recruiting |
| University Hospital Bonn, Medizinische Klinik III | Bonn | Germany | Recruiting |
| Universitaetsklinikum Essen - Klinik fuer Paediatrische Haematologie und Onkologie | Essen | Germany | Terminated |
| Klinikum der Johann Wolfgang Goethe University - University - Klinik fuer Paediatrische Haematologie und Onkologie | Frankfurt | Germany | Recruiting |
| Universitaetsklinikum Freiburg - Zentrum fuer Kinder- und Jugendmedizin (ZKJ) - Klinik fuer Paediatrische Haematologie und Onkologie | Freiburg im Breisgau | Germany | Terminated |
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | Germany | Recruiting |
| Universitatsklinikum | Kiel | Germany | Recruiting |
| University Medical Center Mainz | Mainz | Germany | Recruiting |
| Universitaetsklinikum Mannheim | Mannheim | Germany | Recruiting |
| University Hospital Tuebingen Medical Center | Tübingen | Germany | Recruiting |
| Department of Pediatric Hematology, Oncology and BMT, Wroclaw Medical University | Wroclaw | Lower Silesian Voivodeship | Terminated |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie, Paastwowy Instytut Badawczy | Gliwice | Poland | Recruiting |
| Hospital Germans Trias i Pujol | Badalona | Spain | Recruiting |
| Hospital Universitario Vall dHebron | Barcelona | Spain | Recruiting |
| Institut Catal dOncologia | Barcelona | Spain | Recruiting |
| Hospital Universitario Ramon y Cajal | Madrid | Spain | Recruiting |
| Hospital Puerta De Hierro | Madrid | Spain | Recruiting |
| Hospital Universitario Carlos Haya | Málaga | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia | Valencia | Spain | Recruiting |
+ 2 more sites — see the full list on the official registry below.
More medac GmbH trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04629833 on ClinicalTrials.gov ↗ ← All trials in Spain