RecruitingPhase 3NCT04629833

Treatment Of Steroid-Refractory Acute Graft-versus-host Disease With Mesenchymal Stromal Cells Versus Best Available Therapy

A Randomised, Open-label, Multicentre, Phase 3 Trial of First-line Treatment With Mesenchymal Stromal Cells MC0518 Versus Best Available Therapy in Adult and Adolescent Subjects With Steroid-refractory Acute Graft-versus-host Disease After Allogeneic Haematopoietic Stem Cell Transplantation (IDUNN Trial)

Sponsor

medac GmbH

Enrollment

210 participants

Start Date

Aug 16, 2021

Study Type

INTERVENTIONAL

Conditions

Steroid-refractory Acute Graft Versus Host Disease

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

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called BAT and a biological treatment called MC0518 for people with steroid-refractory acute graft versus host disease. The study is currently recruiting participants at 42 locations. People eligible for this study include aged 12 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALMC0518

MC0518 will be intravenously infused immediately after thawing.

BIOLOGICALBAT

BAT including MMF, ECP, ATG, everolimus, and RUX will be administered based on Investigator's decision.

Locations(42)

Centre Hospitalier Universitaire (CHU) Amiens-Picardie - Hopital Sud

Amiens, France

CHU Jean Minjoz

Besançon, France

Hopital Michallon

Grenoble, France

CHRU Lille- Hopital Claude Huriez

Lille, France

CHU de Nantes - Hotel Dieu

Nantes, France

CHU de Nice Hopital Archet 1

Nice, France

Centre Hospitalier Lyon Sud Pavillon Marcel Berard 1G

Pierre-Bénite, France

Centre Hospitalier Universitaire CHU de Toulouse

Toulouse, France

Hopitaux De Brabois

Vandœuvre-lès-Nancy, France

Klinikum rechts der Isar

Munich, Bavaria, Germany

Universitaetsklinikum Wuerzburg - Medizinische Klinik und Poliklinik II - Zentrum fuer Allogene Blutstammzelltransplantation

Würzburg, Bavaria, Germany

Klinikum der Johann Wolfgang Goethe-Universitaet - Frankfurt am Main

Frankfurt am Main, Hesse, Germany

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Uniklinik Koeln

Cologne, North Rhine-Westphalia, Germany

Universitaetsklinikum Essen - Klinik fuer Knochenmarktransplantation (KMT)

Essen, North Rhine-Westphalia, Germany

Universitaetsklinikum Muenster

Münster, North Rhine-Westphalia, Germany

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, Saxony, Germany

Universitaetsklinikum Leipzig, Selbststaendige Abteilung fur Haematologie und Internistische Onkologie

Leipzig, Saxony, Germany

Universitaetsklinikum Jena Klinik fuer Innere Medizin II, Haematologie und Onkologie

Jena, Thuringia, Germany

Universitaetsklinikum Jena - Klinik fuer Paediatrische Haematologie und Onkologie

Jena, Thuringia, Germany

Charite Universitaetsmedizin

Berlin, Germany

Helios Klinikum Berlin-Buch

Berlin, Germany

University Hospital Bonn, Medizinische Klinik III

Bonn, Germany

Universitaetsklinikum Essen - Klinik fuer Paediatrische Haematologie und Onkologie

Essen, Germany

Klinikum der Johann Wolfgang Goethe University - University - Klinik fuer Paediatrische Haematologie und Onkologie

Frankfurt, Germany

Universitaetsklinikum Freiburg - Zentrum fuer Kinder- und Jugendmedizin (ZKJ) - Klinik fuer Paediatrische Haematologie und Onkologie

Freiburg im Breisgau, Germany

Universitaetsklinikum Freiburg

Freiburg im Breisgau, Germany

Universitatsklinikum

Kiel, Germany

University Medical Center Mainz

Mainz, Germany

Universitaetsklinikum Mannheim

Mannheim, Germany

University Hospital Tuebingen Medical Center

Tübingen, Germany

Department of Pediatric Hematology, Oncology and BMT, Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie, Paastwowy Instytut Badawczy

Gliwice, Poland

Hospital Germans Trias i Pujol

Badalona, Spain

Hospital Universitario Vall dHebron

Barcelona, Spain

Institut Catal dOncologia

Barcelona, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Puerta De Hierro

Madrid, Spain

Hospital Universitario Carlos Haya

Málaga, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Hospital Universitari i politecnic La Fe

Valencia, Spain

Center for Allogeneic Stem Cell Transplantation and Cell Therapy (CAST), Karolinska Universitetssjukhuset Huddinge

Huddinge, Sweden

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NCT04629833

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