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

Primary Purpose

Steroid-refractory Acute Graft-versus-host Disease

Status

Recruiting

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

MC0518

BAT

About this trial

This is an interventional treatment trial for Steroid-refractory Acute Graft-versus-host Disease

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, 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).

Sites / Locations

Centre Hospitalier Universitaire (CHU) Amiens-Picardie - Hopital Sud Avenue Rene Laennec AmiensRecruiting
CHU Jean Minjoz Boulevard Fleming BesanconRecruiting
Hopital MichallonRecruiting
CHRU Lille- Hopital Claude HuriezRecruiting
CHU de Nantes - Hotel Dieu 1 Place Alexis Ricordeau NantesRecruiting
CHU de Nice Hopital Archet 1Recruiting
Centre Hospitalier Lyon Sud Pavillon Marcel Berard 1GRecruiting
Centre Hospitalier Universitaire CHU de ToulouseRecruiting
Hopitaux De BraboisRecruiting
Klinikum rechts der IsarRecruiting
Universitaetsklinikum Wuerzburg - Medizinische Klinik und Poliklinik II - Zentrum fuer Allogene BlutstammzelltransplantationRecruiting
Klinikum der Johann Wolfgang Goethe-Universitaet - Frankfurt am MainRecruiting
Medizinische Hochschule HannoverRecruiting
Universitaetsklinikum MuensterRecruiting
Universitaetsklinikum Essen - Klinik fuer Knochenmarktransplantation (KMT)Recruiting
Uniklinik KoelnRecruiting
Universitaetsklinikum Carl Gustav Carus DresdenRecruiting
Selbststaendige Abteilung fur Haematologie und Internistische OnkologieRecruiting
Universitaetsklinikum JenaRecruiting
Universitaetsklinikum JenaRecruiting
Charite Universitaetsmedizin BerlinRecruiting
Helios Klinikum Berlin-Buch
University Hospital Bonn, Medizinische Klinik IIIRecruiting
Universitaetsklinikum EssenRecruiting
Klinikum der Johann Wolfgang Goethe UniversityRecruiting
Universitaetsklinikum Freiburg - Zentrum fuer Kinder- und Jugendmedizin (ZKJ) - Klinik fuer Paediatrische Haematologie und Onkologie
Universitaetsklinikum FreiburgRecruiting
University Medical Center MainzRecruiting
Universitaetsklinikum MannheimRecruiting
University Hospital Tuebingen Medical CenterRecruiting
Department of Pediatric Hematology, Oncology and BMT, Wroclaw Medical UniversityRecruiting
Hospital Germans Trias i PujolRecruiting
Hospital Universitario Vall dHebronRecruiting
Institut Catal dOncologiaRecruiting
Hospital Universitario Ramon y CajalRecruiting
Hospital Puerta De HierroRecruiting
Hospital Universitario Carlos Haya
Hospital Clinico Universitario de ValenciaRecruiting
Hospital Universitari i politecnic La Fe
Center for Allogeneic Stem Cell Transplantation and Cell Therapy (CAST), Karolinska Universitetssjukhuset Huddinge

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MC0518

Best Available Therapy (BAT)

Arm Description

Participants will receive MC0518 1-2 million cells/ kilogram infusions (based on body weight at the Screening Visit) once a week for 4 weeks (Visit Day 1, 8, 15, and 22). Participants with partial response (PR) on Day 28 will have 2 additional MC0518 infusions administered on Day 29 and 36.

Participants will receive any one of the following systemic BATs based on the Investigator's decision: mycophenolate mofetil (MMF), extracorporeal photopheresis (ECP), anti-thymocyte globulin (ATG), everolimus, and ruxolitinib (RUX).

Outcomes

Primary Outcome Measures

Overall Response (OR)

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.

Secondary Outcome Measures

Freedom from Treatment Failure (FFTF)

FFTF is defined as death, relapse or progression of the underlying disease, or addition or change to any further systemic immunosuppressive aGvHD therapy. Number of participants with FFTF will be reported.

Overall Survival

Overall survival is defined as the time from randomization to the date of death due to any cause.

Acute Graft-versus-host Disease (aGvHD) Response

Number of participants with aGvHD response will be reported. aGvHD response will be categorized as OR (CR + PR), CR, PR, and NR. NR is defined as the absence of CR or PR.

Change from Baseline in aGvHD Grades

aGvHD grades: Grade 0- no organ involvement (ie, Stage 0 skin, Stage 0 liver, and Stage 0 GI); Grade I-Stage 1 - 2 skin without liver/GI involvement; Grade II- Stage 3 skin and / or Stage 1 liver and / or Stage 1 GI; Grade III- Stage 2 - 3 liver and / or Stage 2 - 3 GI; Grade IV- Stage 4 skin and / or Stage 4 liver and/or Stage 4 GI.

Time to Response

Time to response is defined as the time from the date of the first treatment administration to the date of response.

Duration of Response

Duration is calculated from time from the first OR (CR or PR) until the time point of no aGvHD response in comparison to baseline.

Best Overall Response (OR)

Best OR is defined as the achievement of an OR at any time point up to and including Day 28. Number of participants with best OR will be reported.

Cumulative Dose of Steroids for SR-aGvHD per Kilogram (kg) of Body Weight

The cumulative dose of steroids given for SR-aGvHD per kg of body weight from baseline until Day 60 and until Visit Month 24 will be analyzed.

Number of Participants with Chronic Graft-versus-host Disease (cGvHD)

Number of participants with cGvHD will be reported.

Time to Chronic Graft-versus-host Disease (cGvHD)

Time to cGvHD is defined as the time between the last day of haematopoietic stem cell transplantation (HSCT) to the first episode of cGvHD.

Number of Participants with Graft Failure (GF)

Number of participants with GF will be reported.

Number of Participants with Relapse or Progression in Participants with Underlying Malignant Disease

Number of participants with relapse or progression in participants with underlying malignant disease will be reported.

Time to Relapse or Progression in Participants with Underlying Malignant Disease

Time to relapse or progression in participants with underlying malignant disease will be reported.

Event-free survival (EFS)

EFS is defined as the time from the date of randomization to the date of the event. An event is defined as GF, relapse or progression of the underlying disease, or death due to any cause.

Non-relapse Mortality (NRM)

NRM is defined as the time from the date of randomisation to the date of the event. An event is defined as death without previous relapse or progression of the underlying disease.

Number of Participants with Adverse Events (AEs) and Adverse Reactions (ARs)

Number of Participants with Adverse Events (AEs) and Adverse Reactions (ARs) by Severity

Severity will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0: Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening consequences; urgent intervention indicated; Grade 4- Death related to the AE.

Change from Baseline in Performance score based on Karnofsky scale (recipient age >= 16 years)

The Karnofsky performance score (KPS), which is reported on an ordinal scale from 0 to 100, provides a rough measure of the participant's well-being, including their ability to conduct activities of daily living and functional capacity. Higher score indicates normal, no complaints and no evidence of disease.

Change from Baseline in Performance score based on Lansky Scale

A Lansky score (recipient age greater than or equal to [>=] 1 years and less than [<] 16 years) will be recorded pre-treatment and measured serially at regular intervals after treatment. The score is a standard performance score that measures overall function of the child with a scale range from 0 to 100. Higher score indicates full activeness.

Change from Baseline in EuroQol-5D-5L (EQ-5D-5L): Health Status Index (HSI)

EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "TODAY". Responses were used to generate a HSI. HSI ranges from 0 (dead) to 1.00 (full health).

Change from Baseline in EuroQol-5D-5L (EQ-5D-5L): Visual Analogue Scale (VAS)

EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine).

Change from Baseline in Functional Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT) Score

The FACT-BMT questionnaire was designed to measure the quality of life in subjects undergoing bone marrow (BM) transplantation. It consists of the following categories of assessment: physical well-being, social / family well-being, emotional well-being, functional well-being, and additional miscellaneous concerns that the subject may have concerning their healthcare, persons involved in their life, and other emotions and incapabilities. Score ranges from 0-164, with higher score indicating better quality of life.

Full Information

NCT ID

NCT04629833

First Posted

November 9, 2020

Last Updated

April 11, 2023

Sponsor

medac GmbH

1. Study Identification

Unique Protocol Identification Number

NCT04629833

Brief Title

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

Acronym

IDUNN

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)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 16, 2021 (Actual)

Primary Completion Date

January 28, 2024 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

medac GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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) in adult and adolescent participants with steroid-refractory acute graft-versus-host disease (SR-aGvHD) at Day 28.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Steroid-refractory Acute Graft-versus-host Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MC0518

Arm Type

Experimental

Arm Description

Arm Title

Best Available Therapy (BAT)

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

MC0518

Intervention Description

MC0518 will be intravenously infused immediately after thawing.

Intervention Type

Biological

Intervention Name(s)

BAT

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall Response (OR)

Description

Time Frame

Day 28

Secondary Outcome Measure Information:

Title

Freedom from Treatment Failure (FFTF)

Description

Time Frame

Up to 6 months

Title

Overall Survival

Description

Overall survival is defined as the time from randomization to the date of death due to any cause.

Time Frame

Up to Month 24

Title

Acute Graft-versus-host Disease (aGvHD) Response

Description

Number of participants with aGvHD response will be reported. aGvHD response will be categorized as OR (CR + PR), CR, PR, and NR. NR is defined as the absence of CR or PR.

Time Frame

Days 28, 60, 100 and 180

Title

Change from Baseline in aGvHD Grades

Description

Time Frame

Baseline and Days 8, 15, 22, 28, 60, 100 and 180

Title

Time to Response

Description

Time to response is defined as the time from the date of the first treatment administration to the date of response.

Time Frame

Up to Month 24

Title

Duration of Response

Description

Duration is calculated from time from the first OR (CR or PR) until the time point of no aGvHD response in comparison to baseline.

Time Frame

Up to Month 24

Title

Best Overall Response (OR)

Description

Best OR is defined as the achievement of an OR at any time point up to and including Day 28. Number of participants with best OR will be reported.

Time Frame

Up to Day 28

Title

Cumulative Dose of Steroids for SR-aGvHD per Kilogram (kg) of Body Weight

Description

The cumulative dose of steroids given for SR-aGvHD per kg of body weight from baseline until Day 60 and until Visit Month 24 will be analyzed.

Time Frame

Up to Day 60 and Month 24

Title

Number of Participants with Chronic Graft-versus-host Disease (cGvHD)

Description

Number of participants with cGvHD will be reported.

Time Frame

Day 60 to Month 24

Title

Time to Chronic Graft-versus-host Disease (cGvHD)

Description

Time to cGvHD is defined as the time between the last day of haematopoietic stem cell transplantation (HSCT) to the first episode of cGvHD.

Time Frame

Day 60 to Month 24

Title

Number of Participants with Graft Failure (GF)

Description

Number of participants with GF will be reported.

Time Frame

Up to Month 24

Title

Number of Participants with Relapse or Progression in Participants with Underlying Malignant Disease

Description

Number of participants with relapse or progression in participants with underlying malignant disease will be reported.

Time Frame

Up to Month 24

Title

Time to Relapse or Progression in Participants with Underlying Malignant Disease

Description

Time to relapse or progression in participants with underlying malignant disease will be reported.

Time Frame

Up to Month 24

Title

Event-free survival (EFS)

Description

EFS is defined as the time from the date of randomization to the date of the event. An event is defined as GF, relapse or progression of the underlying disease, or death due to any cause.

Time Frame

Up to Month 24

Title

Non-relapse Mortality (NRM)

Description

NRM is defined as the time from the date of randomisation to the date of the event. An event is defined as death without previous relapse or progression of the underlying disease.

Time Frame

Up to Month 24

Title

Number of Participants with Adverse Events (AEs) and Adverse Reactions (ARs)

Time Frame

Until Day 60 or until 30 days after last administration of trial treatment, whichever is later (Up to Month 24)

Title

Number of Participants with Adverse Events (AEs) and Adverse Reactions (ARs) by Severity

Description

Time Frame

Until Day 60 or until 30 days after last administration of trial treatment, whichever is later (Up to Month 24)

Title

Change from Baseline in Performance score based on Karnofsky scale (recipient age >= 16 years)

Description

Time Frame

Baseline, Days 8, 15, 22, 28, 60 and 100

Title

Change from Baseline in Performance score based on Lansky Scale

Description

Time Frame

Baseline, Days 8, 15, 22, 28, 60 and 100

Title

Change from Baseline in EuroQol-5D-5L (EQ-5D-5L): Health Status Index (HSI)

Description

Time Frame

Baseline, Days 28, 60, 100 and 180

Title

Change from Baseline in EuroQol-5D-5L (EQ-5D-5L): Visual Analogue Scale (VAS)

Description

Time Frame

Baseline, Days 28, 60, 100 and 180

Title

Change from Baseline in Functional Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT) Score

Description

Time Frame

Baseline, Days 28, 60, 100 and 180

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philippa Nicholson

Organizational Affiliation

Syneos Health

Official's Role

Study Director

Facility Information:

Facility Name

Centre Hospitalier Universitaire (CHU) Amiens-Picardie - Hopital Sud Avenue Rene Laennec Amiens

City

Amiens

ZIP/Postal Code

80054

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amandine Charbonnier

Phone

+33 3-22-45-60-00

charbonnier.amandine@chu-amiens.fr

Facility Name

CHU Jean Minjoz Boulevard Fleming Besancon

City

Besancon

ZIP/Postal Code

25030

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ana Berceanu

Phone

+33 3 81-66-83-51

aberceanu@chu-besancon.fr

Facility Name

Hopital Michallon

City

Grenoble

ZIP/Postal Code

38700

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dr. Martin Carre

Phone

+ 33 04 76 76 56 63

MCarre1@chu-grenoble.fr

Facility Name

CHRU Lille- Hopital Claude Huriez

City

Lille

ZIP/Postal Code

59000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ibrahim Yakoub Agha

Phone

+33 3-20445713

ibrahim.yakoubagha@chru-lille.fr

Facility Name

CHU de Nantes - Hotel Dieu 1 Place Alexis Ricordeau Nantes

City

Nantes

ZIP/Postal Code

44093

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Patrice Chevallier

Phone

+33 240-083269

patrice.chevallier@chu-nantes.fr

Facility Name

CHU de Nice Hopital Archet 1

City

Nice

ZIP/Postal Code

06200

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Loschi

Phone

+33 4 92 03 5558

loschi.m@chu-nice.fr

Facility Name

Centre Hospitalier Lyon Sud Pavillon Marcel Berard 1G

City

Pierre Benite Cedex

ZIP/Postal Code

69630

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Helene Labussiere-Wallet

Phone

+33 478862210

helene.labussiere-wallet@chu-lyon.fr

Facility Name

Centre Hospitalier Universitaire CHU de Toulouse

City

Toulouse

ZIP/Postal Code

31059

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anne Huynh

Phone

+33 5-31-15-61-89

huynh.anne@iuct-oncopole.fr

Facility Name

Hopitaux De Brabois

City

Vandoeuvre les Nancy

ZIP/Postal Code

54511

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maud D'Aveni-Piney

Phone

+33 383-153-282

m.daveni-piney@chru-nancy.fr

Facility Name

Klinikum rechts der Isar

City

Munich

State/Province

Bavaria

ZIP/Postal Code

81675

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mareike Verbeek

Phone

+49 89-41405336

mareike.verbeek@tum.de

Facility Name

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

City

Wuerzburg

State/Province

Bavaria

ZIP/Postal Code

97080

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sabrina Kraus

Phone

+49 93120140411

kraus_s3@klinik-uni-wuerzburg.de

Facility Name

Klinikum der Johann Wolfgang Goethe-Universitaet - Frankfurt am Main

City

Frankfurt am Main

State/Province

Hessen

ZIP/Postal Code

60590

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gesine Bug

Phone

+49 69-6301

g.bug@em.uni-frankfurt.de

Facility Name

Medizinische Hochschule Hannover

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30625

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gernot Beutel

Phone

+49 511-532-3020

beutel.gernot@mh-hannover.de

Facility Name

Universitaetsklinikum Muenster

City

Muenster

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48149

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Matthias Stelljes

Phone

+49 251-8352801

matthias.stelljes@ukmuenster.de

Facility Name

Universitaetsklinikum Essen - Klinik fuer Knochenmarktransplantation (KMT)

City

Essen

State/Province

North Rhine-Westphalia

ZIP/Postal Code

45147

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rudolf Trenschel

Phone

+49 201-723

rudolf.trenschel@uk-essen.de

Facility Name

Uniklinik Koeln

City

Koeln

State/Province

North Rhine-Westphalia

ZIP/Postal Code

50937

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Udo Holtick

Phone

+49 221-478-85523

udo.holtick@uk-koeln.de

Facility Name

Universitaetsklinikum Carl Gustav Carus Dresden

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01307

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Desiree Kunadt

Phone

+49-351-45819523

desiree.kunadt@uniklinikum-dresden.de

Facility Name

Selbststaendige Abteilung fur Haematologie und Internistische Onkologie

City

Leipzig

State/Province

Saxony

ZIP/Postal Code

04103

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Georg-Nikolaus Franke

Phone

+49 3419713842

georg-nikolaus.franke@medizin.uni-leipzig.de

Facility Name

Universitaetsklinikum Jena

City

Jena

State/Province

Thueringen

ZIP/Postal Code

07740

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Inken Hilgendorf

Phone

+49 3641-9-324513

inken.hilgendorf@med.uni-jena.de

Facility Name

Universitaetsklinikum Jena

City

Jena

State/Province

Thueringen

ZIP/Postal Code

07747

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bernd Gruhn

Phone

+49 3641-9329574

bernd.gruhn@med.uni-jena.de

Facility Name

Charite Universitaetsmedizin Berlin

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Johannes Schulte

Phone

+49 030-450-566-132

johannes.schulte@charite.de

Facility Name

Helios Klinikum Berlin-Buch

City

Berlin

ZIP/Postal Code

287706

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Judith Niederland

judith.niederland@helios-gesundheit.de

Facility Name

University Hospital Bonn, Medizinische Klinik III

City

Bonn

ZIP/Postal Code

53127

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tobias Holderried

Phone

+49 228-287-17233

tobias.holderried@ukbonn.de

Facility Name

Universitaetsklinikum Essen

City

Essen

ZIP/Postal Code

45147

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Oliver Basu

Phone

+49 201-723-5165

o.basu@uk-essen.de

Facility Name

Klinikum der Johann Wolfgang Goethe University

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter Bader

Phone

+49 69-6301-7541

peter.bader@kgu.de

Facility Name

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

City

Freiburg im Breisgau

ZIP/Postal Code

151595

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brigitte Strahm

brigitte.strahm@uniklinik-freiburg.de

Facility Name

Universitaetsklinikum Freiburg

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert Zeiser

Phone

+49 076-127034580

robert.zeiser@uniklinik-freiburg.de

Facility Name

University Medical Center Mainz

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eva Wagner-Drouet

Phone

+49 6131-172712

eva.wagner@unimedizin-mainz.de

Facility Name

Universitaetsklinikum Mannheim

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stefan Klein

Phone

+49 621-3830

stefan.klein@umm.de

Facility Name

University Hospital Tuebingen Medical Center

City

Tuebingen

ZIP/Postal Code

72076

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wolfgang Bethge

Phone

+49 70712983176

wolfgang.bethge@med.uni-tuebingen.de

Facility Name

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

City

Wrocław

State/Province

Dolnoslaskie

ZIP/Postal Code

50-556

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Krzysztof Kalwak

Phone

+48 4871-7332840

krzysztof.kalwak@gmail.com

Facility Name

Hospital Germans Trias i Pujol

City

Badalona

ZIP/Postal Code

08916

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anna Torrent Catarineu

Phone

+34 93-497-89-87

atorrent@iconcologia.net

Facility Name

Hospital Universitario Vall dHebron

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria Sola Soto

Phone

+34 93 2746000

mariasola@vhio.net

Facility Name

Institut Catal dOncologia

City

Barcelona

ZIP/Postal Code

08908

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alberto Mussetti

Phone

+34 667-069-283

amussetti@iconcologia.net

Facility Name

Hospital Universitario Ramon y Cajal

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Francisco Javier Lopez Jimenez

Phone

+34 91-3368637

jljimenez@salud.madrid.org

Facility Name

Hospital Puerta De Hierro

City

Madrid

ZIP/Postal Code

28222

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rafael Duarte Palomino

Phone

+34 911916303

rduarte.work@gmail.com

Facility Name

Hospital Universitario Carlos Haya

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria Jesus Pascual

Phone

+34-951-29 00 00

mjcascon@gmail.com

Facility Name

Hospital Clinico Universitario de Valencia

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carlos Solano

Phone

+34 96-1973838

carlos.solano@uv.es

Facility Name

Hospital Universitari i politecnic La Fe

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jaime Sanz Cabeller

Phone

+34-96-12 44 929

sanz_jai@gva.es

Facility Name

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

City

Huddinge

ZIP/Postal Code

126464

Country

Sweden

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stephan Mielke

Phone

+46 0725955987

stephan.mielke@ki.se

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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