Feasibility Trial of Extracorporeal Iron Purification in Patients With Myelodysplastic Syndrome or Myelofibrosis

Launched by HOSPICES CIVILS DE LYON · Jan 13, 2025

Keywords

ClinConnect Summary

This clinical trial, called MEXIRON, is exploring a new device, the MEX-CD1, designed to help patients with myelodysplastic syndrome (MDS) or myelofibrosis who need regular blood transfusions. These transfusions can lead to an excess of iron in the body, which may harm organs and increase the risk of infections. The MEX-CD1 device aims to safely reduce this excess iron without the unpleasant side effects often associated with standard oral treatments. The trial will assess how well this device works, its safety, and how it affects patients' quality of life.

To be eligible for this trial, participants need to have a diagnosis of MDS or myelofibrosis and meet certain health criteria, such as having severe anemia and a specific level of iron in their blood. They must also be unable to tolerate current iron-reducing treatments. If chosen to participate, individuals will undergo three treatment sessions within a week and will have follow-up visits to monitor their progress for up to three months. This study is not yet recruiting participants, but it could offer a new option for those struggling with iron overload from their treatments.

Gender

ALL

Eligibility criteria

• 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.
• • 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.