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

Sponsor
Hospices Civils de Lyon
Study ID
NCT06781099
Status
Recruiting
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Conditions

  • Myelodysplastic Syndrome
  • Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jan 17, 2025
Start date
Jan 6, 2026
Status verified
Mar 2026
Primary completion
Jan 6, 2027
Completion
May 6, 2027

Study Design

Enrollment
13 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Performance of MEX-CD1 on total iron chelation during a session epuration. [ Time Frame: Day 4 ]

Central Contacts

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