Clinical trial NCT06781099: Feasibility Trial of Extracorporeal Iron Purification in Patients With Myelodysplastic Syndrome or Myelofibrosis
Official title: Feasibility, Tolerability and Efficacy of Extracorporeal Iron Purification in Patients With Myelodysplastic Syndrome or Myelofibrosis Intolerant of or Contraindicated to Oral or Subcutaneous Chelation Treatment.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Myelodysplastic Syndrome
Myelofibrosis
Keywords: Myelodysplastic syndrome
myelofibrosis
iron chelation therapy
haemodialysis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: MEXBrain 13 avenue Albert Einstein 69100 Villeurbanne
First posted: 2025-01-17
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility, prospective, monocentric, pilot clinical investigation
Primary purpose: TREATMENT

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 serum 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 serum free 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: 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.
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Performance of MEX-CD1 on total iron chelation during a session epuration.
timeFrame: Day 4
Secondary outcomes:
measure: Performance of MEX-CD1 on iron profile.
timeFrame: Day 4
measure: Safety of MEX-CD1 use
timeFrame: week 16
measure: Impact on blood products patient's needs.
timeFrame: week 16
measure: Feasibility of MEX-CD1 use
timeFrame: Day 4
measure: Patient's reported tolerability of low-volume continuous veno-venous hemodialysis cycle.
timeFrame: Day 4
measure: Patient's reported quality of life.
timeFrame: Week 16
Other outcomes:
Locations:
city: Oullins-Pierre-Bénite
country: France
facility: Hôpital Lyon Sud
city: Oullins-Pierre-Bénite
country: France
facility: Hôpital Lyon Sud
Study officials:
References: