Extracorporeal iron purification with MEX-CD1 for patients with MDS or myelofibrosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The MEXIRON feasibility trial uses the MEX-CD1 device to perform extracorporeal chelation via low-volume continuous veno-venous haemodialysis to reduce iron overload. Enrolled patients will undergo three low-volume continuous veno-venous haemodialysis sessions with MEX-CD1 and be followed for changes in serum ferritin, hepatic and cardiac iron measures, transfusion needs, safety events, and quality of life. The trial enrolls adults with transfusion-dependent MDS or myelofibrosis who meet predefined iron-overload thresholds and who have intolerance or contraindications to oral or subcutaneous chelation. Safety monitoring focuses on haemodynamic stability and anticoagulation-related risks associated with the extracorporeal procedure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 known allergy or contraindication to heparin or citrate.
* Patients undergoing azacitidine or other chemotherapy (or considered as such) for myelodysplastic syndrome or myelofibrosis.
* Patient who received treatment with luspatercept or erythropoietin (EPO) during the month prior to inclusion.
* Patients with indications for allogeneic bone marrow transplantation.
* 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 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.
* Patients under psychiatric care.
* Patient deprived of liberty by judicial or administrative decision.
* Pregnant or breast-feeding women.

Where it's running

• Hôpital Lyon Sud
  Oullins-Pierre-Bénite, France Recruiting
• Hôpital Lyon Sud
  Oullins-Pierre-Bénite, France Recruiting

Study contacts

• Study coordinator: Auguste DARGENT, MD, PhD
• Email: auguste.dargent@chu-lyon.fr
• Phone: +33 478 862 0026

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.