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Compares treatment options for Steroid-refractory Acute Graft-versus-host Disease
Official title Treatment Of Steroid-Refractory Acute Graft-versus-host Disease With Mesenchymal Stromal Cells Versus Best Available Therapy
ClinicalTrials.gov ID: NCT04629833
What this study is testing
What is MC0518?
MC0518 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for steroid-refractory acute graft-versus-host disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Participant had a previous allogeneic HSCT as indicated for non-malignant (including inborn errors of metabolism, primary immunodeficiencies...
- 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...
- 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
You likely can't join if
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Besançon, France
- Grenoble, France
- Lille, France
- Nantes, France
- Nice, France
- Pierre-Bénite, France
- Toulouse, France
- Vandœuvre-lès-Nancy, France
- Munich, Bavaria, Germany
- Würzburg, Bavaria, Germany
- Frankfurt am Main, Hesse, Germany
- Hanover, Lower Saxony, Germany
- Cologne, North Rhine-Westphalia, Germany
- Essen, North Rhine-Westphalia, Germany
- Münster, North Rhine-Westphalia, Germany
- Dresden, Saxony, Germany
- Leipzig, Saxony, Germany
- Jena, Thuringia, Germany
- Berlin, Germany
+ 16 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Besançon, France; Grenoble, France; Lille, France; Nantes, France; Nice, France and 30 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.