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

NCT06781099 | Recruiting DMC

• 2 other identifiers: 69HCL23_01022024-A02473-44
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Myelofibrosis; Myelodysplastic Syndrome

Keywords

Myelodysplastic syndrome; myelofibrosis; iron chelation therapy; haemodialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Performance of MEX-CD1 on iron profile.

  Day 4

• Performance of MEX-CD1 on iron profile.

  Day 4

• Safety of MEX-CD1 use

  week 16

• Impact on blood products patient's needs.

  week 16

• Feasibility of MEX-CD1 use

  Day 4

Study Arms (1)

Experimental: low-volume continuous veno-venous haemodialysis with MEX-CD1 use

EXPERIMENTAL

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

Interventions

Low-volume continuous veno-venous haemodialysis with MEX-CD1 use 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 3h20 each. For non-hospitalized patients, the treatment is performed on an outpatient basis.

Experimental: low-volume continuous veno-venous haemodialysis with MEX-CD1 use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient followed for myelodysplastic syndrome or myelofibrosis.
• Patients with severe anemia and hemoglobin \<70 g/L at baseline.
• Patient with intolerance or contraindication to oral or subcutaneous chelation therapy.
• Patient able to understand (French-speaking) and comply with protocol, having signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead
• MEXBrain 13 avenue Albert Einstein 69100 Villeurbanne: collaborator

Study Sites (2)

Hôpital Lyon Sud

Oullins-Pierre-Bénite, 69495, France

RECRUITING

Hôpital Lyon Sud

Oullins-Pierre-Bénite, 69495, France

RECRUITING

MeSH Terms

Conditions

Myelodysplastic Syndromes; Primary Myelofibrosis

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Myeloproliferative Disorders

Central Study Contacts

Auguste DARGENT, MD, PhD

CONTACT

+33 478 862 0026; auguste.dargent@chu-lyon.fr

Bernard ALLAOUCHICHE, MD

CONTACT

04 78 86 23 42; bernard.allaouchiche@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility, prospective, monocentric, pilot clinical investigation

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 17, 2025
• Study Start: January 6, 2026
• Primary Completion (Estimated): January 6, 2027
• Study Completion (Estimated): May 6, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-03

Locations

FR (2)