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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Myelofibrosis; Myelodysplastic Syndrome
• Intervention / Treatment: Device: Low-volume continuous veno-venous haemodialysis with MEX-CD1 use

• Study Type: Interventional
• Enrollment (Estimated): 13
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Auguste DARGENT, MD, PhD; Phone Number: +33 478 862 0026; Email: auguste.dargent@chu-lyon.fr
• Study Contact Backup: Name: Bernard ALLAOUCHICHE, MD; Phone Number: +33 04 78 86 23 42; Email: bernard.allaouchiche@chu-lyon.fr

Study Locations

• France
  • Oullins-Pierre-Bénite, France, 69495
    • Recruiting
    • Hôpital Lyon Sud
    • Contact: Maël HEIBLIG, MD, PhD; Phone Number: +33 478 862 210; Email: mael.heiblig@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental: low-volume continuous veno-venous haemodialysis with MEX-CD1 use; Patients enrolled will benefit 3 consecutive cycle of low volume continuous veno-venous haemodialysis using MEX-CD1 treatment.

Device: Low-volume continuous veno-venous haemodialysis with MEX-CD1 use; MEX-CD1 is a hyper-chelating colloidal solution that can be added to the dialysate to be used in low-volume continuous veno-venous hemodialysis. Intervention includes 3 low-volume continuous veno-venous hemodialysis for a duration of 3h20 each. For non-hospitalized patients, the treatment is performed on an outpatient basis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of MEX-CD1 on total iron chelation during a session epuration.	Quantity of iron values measured in the effluent bag (Hf) during each low-volume continuous veno-venous hemodialysis cycle	Day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of MEX-CD1 use	Assessment of adverse events during low-volume continuous veno-venous hemodialysis cycles and all follow up period.	week 16
Impact on blood products patient's needs.	Assessment on patient's red blood cells administration from the start of the first MEX-CD1 treatment until the follow-up ending.	week 16
Feasibility of MEX-CD1 use	Assessment of patient's proportion who will have performed i) the entire first low-volume continuous veno-venous hemodialysis cycle and ii) the whole weakly 3 consecutive cycles at the end of the third low-volume continuous veno-venous hemodialysis cycle.	Day 4
Patient's reported tolerability of low-volume continuous veno-venous hemodialysis cycle.	Patients tolerability assessment by Visual Analog Scales (VAS) on painful and asthenia feelings at the end of each low-volume continuous veno-venous hemodialysis cycle.	Day 4
Patient's reported quality of life.	Quality of life assessment by the Medical Outcome Study Short Form 12 from the inclusion visit until end of follow-up.	Week 16
Performance of MEX-CD1 on iron profile.	Amount of iron measured on the effluent line (H1, H2, Hf) during each Extracorporeal Purification session	Day 4
Performance of MEX-CD1 on iron profile.	Variations in iron, ferritin and transferrin values from the start until i) each low-volume continuous veno-venous hemodialysis cycle ending (Hf) and ii) after 3 low-volume continuous veno-venous hemodialysis cycles	Day 4

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Collaborators: MEXBrain 13 avenue Albert Einstein 69100 Villeurbanne

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2026
• Primary Completion (Estimated): January 6, 2027
• Study Completion (Estimated): May 6, 2027

Study Registration Dates

• First Submitted: January 8, 2025
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): January 17, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: haemodialysis; myelofibrosis; Myelodysplastic syndrome; iron chelation therapy
• Additional Relevant MeSH Terms: Hematologic Diseases; Bone Marrow Diseases; Myeloproliferative Disorders; Hemic and Lymphatic Diseases; Myelodysplastic Syndromes; Primary Myelofibrosis
• Other Study ID Numbers: 69HCL23_0102; 2024-A02473-44 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No