Iron Reduction Device for Myelodysplastic Syndrome
Feasibility Trial of Extracorporeal Iron Purification in Patients With Myelodysplastic Syndrome or Myelofibrosis
Recruiting
N/A
Interventional Study
Myelodysplastic Syndrome
Myelofibrosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 13 (estimated)
- Sponsor
- Hospices Civils de Lyon · Other
Who this trial is looking for
This trial is looking for patients with myelodysplastic syndrome or myelofibrosis who need regular blood transfusions. Participants will use a special device to help reduce excess iron in their bodies and will have follow-up visits to monitor their health.
Are You a Good Fit for This Trial?
You may be able to join if
- I have been diagnosed with myelodysplastic syndrome or myelofibrosis.
- I have a platelet count of 50 or more.
- I have severe anemia with hemoglobin less than 70 g/L.
- I cannot tolerate oral or subcutaneous iron treatments.
- My ferritin level is above 1000 µg/L or I have a specific iron measurement problem.
- I can understand French and follow study rules.
- I agree to sign a consent form.
You may not be able to join if
- I have primary hemochromatosis.
- I weigh less than 30 kg.
- I have an allergy to heparin or citrate.
- I am receiving chemotherapy for my blood condition.
- I have received treatment with luspatercept or EPO in the last month.
- I need a bone marrow transplant.
- I am allergic to shellfish.
- I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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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…
Trial Locations
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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.
*…
Contacts