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New treatment option for Myelodysplastic Syndrome
Official title Feasibility Trial of Extracorporeal Iron Purification in Patients With Myelodysplastic Syndrome or Myelofibrosis
ClinicalTrials.gov ID: NCT06781099
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join 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.
- Patient who received treatment with luspatercept or erythropoietin (EPO) during the month prior to inclusion.
- Patients with indications for allogeneic bone marrow transplantation.
See the full eligibility 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.
- 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.
- Patient who received treatment with luspatercept or erythropoietin (EPO) during the month prior to inclusion.
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Oullins-Pierre-Bénite, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oullins-Pierre-Bénite, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.