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

ConditionsMyelodysplastic SyndromeMyelofibrosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospices Civils de Lyon

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

13 Participants
are divided into 1 treatment group
Group A: Experimental: low-volume continuous veno-venous haemodialysis with MEX-CD1 useExperimental treatment 1 intervention

Trial outcomes

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

Time frame
Day 4

Secondary outcomes

1

Performance of MEX-CD1 on iron profile.

Amount of iron measured on the effluent line (H1, H2, Hf) during each Extracorporeal Purification session

Time frame
Day 4
2

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

Time frame
Day 4
3

Safety of MEX-CD1 use

Assessment of adverse events during low-volume continuous veno-venous hemodialysis cycles and all follow up period.

Time frame
week 16
4

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.

Time frame
week 16

Other outcomes

1

Exploratory ancillary outcome: trace metal quantification

Quantification of copper, zinc, selenium, cadmium and lead in plasma and effluent samples to assess the specificity of MEX-CD1 chelation.

Time frame
From inclusion to Day 28

Locations

2

Map coordinates are unavailable for these locations. Locations are shown below instead.

Hôpital Lyon SudRecruiting69495, Oullins-Pierre-BéniteFranceFrance
Hôpital Lyon SudRecruiting69495, Oullins-Pierre-BéniteFranceFrance

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospices Civils de Lyon

Lead sponsor

MEXBrain 13 avenue Albert Einstein 69100 Villeurbanne

Collaborator

Source ClinicalTrials.gov
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