NCT06781099Recruiting
Feasibility Trial of Extracorporeal Iron Purification in Patients With Myelodysplastic Syndrome or Myelofibrosis
Feasibility, Tolerability and Efficacy of Extracorporeal Iron Purification in Patients With Myelodysplastic Syndrome or Myelofibrosis Intolerant of or Contraindicated to Oral or Subcutaneous Chelation Treatment.
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 13 (estimated)
- First submitted
- 8 Jan 2025
- Start date
- 6 Jan 2026
- Primary completion date
- 6 Jan 2027
- Lead sponsor
- Hospices Civils de Lyon
- NCT number
- NCT06781099
What you commit to
- Study type: Interventional
- Planned participants: 13
- From 6 Jan 2026 to the primary completion date, 6 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient who received treatment with luspatercept or erythropoietin (EPO) during the month prior to inclusion.
- Patients with indications for allogeneic bone marrow transplantation.
Other illness
- Patients with a known allergy or contraindication to heparin or citrate.
- Patients undergoing azacitidine or other chemotherapy (or considered as such) for myelodysplastic syndrome or myelofibrosis.
- Patients with a known allergy to shellfish (MEX-CD1 contains chitosan of animal origin) or to one of the other components of MEX-CD1.
- Patients under psychiatric care.
Other
- Patients with primary hemochromatosis (transferrin saturation coefficient CS-Tf \> 45%).
- Patients with a contraindication to the use of MEX-CD1: weight \< 30 kg, iron deficiency.
- Patients with a peripheral vascular access that is difficult to access or that needs to be preserved.
- Patients participating in other interventional research that could interfere with the results of the study.
- Patients under legal protection or unable to express their consent.
- Patient deprived of liberty by judicial or administrative decision.
- Pregnant or breast-feeding women.
Who the study is looking for
- Patient followed for myelodysplastic syndrome or myelofibrosis.
- Patient with platelet count ≥50 giga/L at inclusion.
- Patients with severe anemia and hemoglobin \<70 g/L at baseline.
- Patient with intolerance or contraindication to oral or subcutaneous chelation therapy.
- Ferritinemia \>1000 µg/L or hepatic iron concentration ≥7 mg/g or cardiac T2\* \<20 ms at inclusion.
- Patient able to understand (French-speaking) and comply with protocol, having signed informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Lyon Sud Coordinator of this site? Confirm its status | Oullins-Pierre-Bénite | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.