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

Hospices Civils de Lyon13 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myelodysplastic Syndrome Myelofibrosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. * 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 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.

Outcomes

Primary Outcomes

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

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

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

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

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

Feasibility of MEX-CD1 use

Assessment of patient's proportion who will have performed i) the entire first low-volume continuous veno-venous hemodialysis cycle and ii) the whole weakly 3 consecutive cycles at the end of the third low-volume continuous veno-venous hemodialysis cycle.

Time frame: Day 4

Patient's reported tolerability of low-volume continuous veno-venous hemodialysis cycle.

Patients tolerability assessment by Visual Analog Scales (VAS) on painful and asthenia feelings at the end of each low-volume continuous veno-venous hemodialysis cycle.

Time frame: Day 4

Patient's reported quality of life.

Quality of life assessment by the Medical Outcome Study Short Form 12 from the inclusion visit until end of follow-up.

Time frame: Week 16

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts