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

NCT ID: NCT06781099

Last Updated: 2026-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-06
• Study Completion Date: 2027-05-06

Brief Summary

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 serum 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 serum free 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.

Conditions

Myelodysplastic Syndrome; Myelofibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Low-volume continuous veno-venous haemodialysis with MEX-CD1 use

Intervention Type: DEVICE

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 4 hours each. For non-hospitalized patients, the treatment is performed on an outpatient basis.

Interventions

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 4 hours each. For non-hospitalized patients, the treatment is performed on an outpatient basis.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MEXBrain 13 avenue Albert Einstein 69100 Villeurbanne

UNKNOWN

Sponsor Role: collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Lyon Sud

Oullins-Pierre-Bénite, , France

Site Status: RECRUITING

Hôpital Lyon Sud

Oullins-Pierre-Bénite, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Auguste DARGENT, MD, PhD

Role: CONTACT

auguste.dargent@chu-lyon.fr

+33 478 862 0026

Bernard ALLAOUCHICHE, MD

Role: CONTACT

bernard.allaouchiche@chu-lyon.fr

04 78 86 23 42 ext. +33

Facility Contacts

Auguste DARGENT, MD, PhD

Role: primary

auguste.dargent@chu-lyon.fr

+33 478 862 006

Maël HEIBLIG, MD, PhD

Role: primary

mael.heiblig@chu-lyon.fr

+33 478 862 210

Other Identifiers

2024-A02473-44

Identifier Type: REGISTRY

Identifier Source: secondary_id

69HCL23_0102

Identifier Type: -

Identifier Source: org_study_id