Trial of Efficacy and Safety of MC0518 Versus Best Available Therapy in Participants With Steroid-Refractory Acute Graft Versus Host Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
MC0518: MC0518 will be intravenously infused immediately after thawing.
BAT: BAT including ECP, ATG, etanercept, infliximab or RUX will be administered based on Investigator's decision.
Study summary
The purpose of this trial is the comparative evaluation of overall response rate (ORR) in paediatric participants with steroid-refractory acute graft-versus-host disease (SR-aGvHD) at Visit Day 28 after treatment with MC0518 or first used best available therapy (BAT).
Eligibility
Primary outcome measure(s)
- Number of Participants With Overall Response (OR) — At Day 28
OR is defined as complete response (CR) or partial response (PR) at Day 28 relative to acute graft-versus-host disease (aGvHD) status at baseline. CR is defined as resolution of aGvHD in all involved organs. PR is defined as improvement in 1 stage in at least 1 or more organs involved with aGvHD symptoms without progression in others.
Trial sites (36)
| Facility | City | Region | Status |
|---|---|---|---|
| CHU de Bordeaux - Hopital des Enfants | Bordeaux | France | |
| CHU Grenoble Alpes - Hopital Couple Enfant (HCE) | La Tronche | France | |
| Centre Hospitalier Universitaire de Lille CHU Lille - Hopital Jeanne de Flandre HJF | Lille | France | |
| Institut d'Hematologie et d'Oncologie Pediatrique (IHOPe) | Lyon | France | |
| CHU de Marseille-Hopital de la Timone | Marseille | France | |
| Centre Hospitalier Regional Universitaire (CHRU) Montpellier - hopital Arnaud de Villeneuve | Montpellier | France | |
| CHU de Nantes - Hopital Mere Enfant | Nantes | France | |
| Hopital Robert Debre | Paris | France | |
| CHU de Rouen - Hopital Charles Nicolle | Rouen | France | |
| CHRU de Strasbourg - Hopital de Hautepierre | Strasbourg | France | |
| CHRU Nancy, Hopitaux de Brabois | Vandœuvre-lès-Nancy | France | |
| Uniklinik RWTH Aachen, Klinik fur Kinder- und Jugendmedizin | Aachen | Germany | |
| Universitaetsklinikum Essen | Essen | Germany | |
| Klinikum der Johann Wolfgang Goethe | Frankfurt | Germany | |
| Universitaetsklinikum Freiburg - Zentrum fuer Kinder- und Jugendmedizin (ZKJ) | Freiburg im Breisgau | Germany | |
| Justus-Liebig-Universitaet Giessen | Giessen | Germany | |
| Medizinische Hochschule Hannover MHH | Hanover | Germany | |
| Department of Pediatrics, Jena University Hospital | Jena | Germany | |
| Universitaetsklinikum Leipzig - Abteilung fuer Paediatrische Onkologie, Haematologie und Haemostaseologie | Leipzig | Germany | |
| Universitaetsklinikum Muenster (UKM) - Klinik fuer Kinder- und Jugendmedizin - Paediatrische Haematologie und Onkologie | Münster | Germany | |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola Malpighi | Bologna | Italy | |
| Pediatric Clinic Onco Hematology San Gerardo Hospital | Monza | Italy | |
| U.O.C. Oncoematologia Pediatrica, Fondazione IRCCS Policlinico San Matteo | Pavia | Italy | |
| Hematology and Cellular Therapy Ospedale Bambino Gesu | Rome | Italy | |
| A.O.U. Citta della Salute e della Scienza di Torino Ospedale Infantile Regina Margherita | Turin | Italy | |
| Department of Pediatric Hematology, Oncology and BMT, Wroclaw Medical University | Wroclaw | Lower Silesian Voivodeship | |
| Dzieciecy Szpital Kliniczny im. A.Gebali w Lublinie | Lublin | Poland | |
| Szpital Kliniczny im. Karola Jonschera UM | Poznan | Poland | |
| Hospital Niño Jesus | Madrid | Madrid | |
| Clinica Universitaria de Navarra | Pamplona | Navarre | |
| Hospital Universitario Vall dHebron | Barcelona | Spain | |
| Hospital Sant Joan de Deu Barcelona (HSJDB) | Barcelona | Spain | |
| Hospital Infantil Universitario La Paz | Madrid | Spain | |
| Instituto de Investigacion Biomedica de Malaga IBIMA - sede Hospital Regional Universitario de Malaga HRUM Hospital Carlos Haya | Málaga | Spain | |
| Instituto Murciano de Investigacion Biosanitaria (IMIB) Virgen de la Arrixaca | Murcia | Spain | |
| Hospital Universitari I politecnic La Fe Jose | Valencia | Spain |
More medac GmbH trials in Italy
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 NCT06075706 on ClinicalTrials.gov ↗ ← All trials in Italy