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RECRUITING

NCT04629833

PHASE3

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

Sponsor: medac GmbH

View on ClinicalTrials.gov

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).

Official title: 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)

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2021-08-16

Completion Date

2030-08

Last Updated

2025-08-13

Healthy Volunteers

Conditions

Steroid-refractory Acute Graft-versus-host Disease

Interventions

BIOLOGICAL

MC0518

MC0518 will be intravenously infused immediately after thawing.

BIOLOGICAL

BAT

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

Inclusion Criteria: * Participant had a previous allogeneic HSCT as indicated for non-malignant (including inborn errors of metabolism, primary immunodeficiencies, haemoglobinopathies, and bone marrow failure syndromes) or haematological malignant disease, irrespective of human leukocyte antigen match * Participant has been clinically diagnosed with Grade II to IV aGvHD at the Screening Visit * Participant has experienced failure of previous first-line aGvHD treatment (ie, SR-aGvHD), defined as: a) aGvHD progression within 3 to 5 days of therapy onset with \>= 2 mg/kg/day of prednisone equivalent or b) failure to improve within 5 to 7 days of treatment initiation with \>= 2 mg/kg/day of prednisone equivalent or c) incomplete response after \> 28 days of immunosuppressive treatment including at least 5 days with \>= 2 mg/kg/day of prednisone equivalent * Participant has an estimated life expectancy \> 28 days at the Screening Visit * Male or female participant who is \>= 12 years of age at the Screening Visit Exclusion Criteria: * Participant has overt relapse or progression or persistence of the underlying disease at the Screening Visit * Participant has received the last HSCT for a solid tumour disease * Participant has GvHD overlap syndrome at the Screening Visit * Participant has received systemic first line treatment for aGvHD other than steroids and a prophylaxis with other than calcineurin inhibitors, mammalian target of rapamycin (mTOR) inhibitors, anti-thymocyte globulin (ATG), mycophenolate mofetil (MMF), methotrexate (MTX), and / or cyclophosphamide before the Screening Visit * Participant has a known pregnancy (as confirmed by a positive pregnancy test at the Screening Visit) and or is breastfeeding at the Screening Visit * Participant has received treatment with any other investigational agent within 30 days or 5 half-lives (whichever is longer) before the Screening Visit (compliance to be confirmed for the period between the Screening Visit and the Baseline Visit at the Baseline Visit).

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