Actively Recruiting
Feasibility Trial of Extracorporeal Iron Purification in Patients With Myelodysplastic Syndrome or Myelofibrosis
Led by Hospices Civils de Lyon · Updated on 2026-04-23
13
Participants Needed
2
Research Sites
69 weeks
Total Duration
On this page
Sponsors
H
Hospices Civils de Lyon
Lead Sponsor
M
MEXBrain 13 avenue Albert Einstein 69100 Villeurbanne
Collaborating Sponsor
AI-Summary
What this Trial Is About
In transfusion-dependent myelodysplastic syndromes patients, regular blood transfusions lead to iron overload, which can cause organ damage, hormonal imbalances, and increased infection risk, ultimately impacting patient survival. Standard oral iron chelation therapies can be intolerable for some patients due to adverse effects. The MEX-CD1 device (class III) could potentially offer an alternative for these patients by reducing serum iron levels through a novel, extracorporeal approach. MEXIRON clinical investigation focuses on the use of MEX-CD1, a medical device designed for extracorporeal chelation therapy to reduce iron overload in patients suffering from transfusion-dependent myelodysplastic syndromes (MDS) and myelofibrosis. MEXIRON aims to evaluate the device's use feasibility, safety, and effectiveness in reducing iron levels. Transfusions needs, patient experience and quality of life are also assessed. Each enrolled patients will undergo three low-volume continuous veno-venous haemodialysis cycles within one week. Following the three- haemodialysis cycles, patients will be monitored through on-site follow-up visits at 7 days, 28 days, and 90 days post-treatment to assess long-term effects.
CONDITIONS
Official Title
Feasibility Trial of Extracorporeal Iron Purification in Patients With Myelodysplastic Syndrome or Myelofibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient followed for myelodysplastic syndrome or myelofibrosis.
- Platelet count of 50 giga/L or higher at inclusion.
- Severe anemia with hemoglobin less than 70 g/L at baseline.
- Intolerance or contraindication to oral or subcutaneous chelation therapy.
- Ferritinemia greater than 1000 g/L or hepatic iron concentration of at least 7 mg/g or cardiac T2* less than 20 ms at inclusion.
- Ability to understand (French-speaking) and comply with protocol, with signed informed consent.
You will not qualify if you...
- Primary hemochromatosis with transferrin saturation coefficient above 45%.
- Contraindication to MEX-CD1 use: weight under 30 kg or iron deficiency.
- Known allergy or contraindication to heparin or citrate.
- Undergoing or considered for azacitidine or other chemotherapy for MDS or myelofibrosis.
- Received luspatercept or erythropoietin treatment in the month before inclusion.
- Indications for allogeneic bone marrow transplantation.
- Known allergy to shellfish or any components of MEX-CD1.
- Peripheral vascular access that is difficult to access or needs preservation.
- Participation in other interventional research that might affect study results.
- Under legal protection or unable to give consent.
- Under psychiatric care.
- Deprived of liberty by judicial or administrative decision.
- Pregnant or breastfeeding women.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Hôpital Lyon Sud
Oullins-Pierre-Bénite, France, 69495
Actively Recruiting
2
Hôpital Lyon Sud
Oullins-Pierre-Bénite, France, 69495
Actively Recruiting
Research Team
A
Auguste DARGENT, MD, PhD
CONTACT
B
Bernard ALLAOUCHICHE, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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