Extracorporeal iron purification with MEX-CD1 for patients with MDS 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.
This study will try using an external blood-filter device (MEX-CD1) to remove excess iron in transfusion-dependent patients with myelodysplastic syndrome or myelofibrosis who cannot tolerate standard chelation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 13 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Oullins-Pierre-Bénite and 1 other locations) |
| Trial ID | NCT06781099 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are transfusion-dependent adults with MDS or myelofibrosis who have iron overload (e.g., ferritin >1000 µg/L or hepatic iron ≥7 mg/g or cardiac T2* <20 ms), platelet count ≥50 G/L, and intolerance or contraindication to oral or subcutaneous chelation.
Not a fit: Patients unlikely to benefit include those with primary hemochromatosis or iron deficiency, weight under 30 kg, allergy or contraindication to heparin or citrate, or those receiving chemotherapy or treated recently with luspatercept or erythropoietin.
Why it matters
Potential benefit: If successful, the device could lower iron burden and organ damage and provide an alternative for patients who cannot use standard iron chelation.
How similar studies have performed: Standard oral iron chelation is established, but extracorporeal iron-chelation devices like MEX-CD1 are largely novel and have limited prior clinical data in MDS/myelofibrosis.
Eligibility criteria
Show full inclusion / exclusion 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. * 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 this trial is running
Oullins-Pierre-Bénite and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.