Magnetic Resonance Imaging (MRI) Assessments of the Heart and Liver Iron Load in Patients With Transfusion Induced Iron Overload

A Study of Magnetic Resonance Imaging Assessment of Cardiac and Liver Iron Load in Patients With Haemoglobinopathies, Myelodysplastic Syndromes (MDS) or Other Anaemias Treated With Exjade® (Deferasirox) (The MILE Study)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00673608

Enrollment

118

Registered

2008-05-07

Start date

2007-11-30

Completion date

2011-09-30

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diamond-Blackfan Anemia, Hemoglobinopathies, MPD Syndrome, Myelodysplastic Syndromes, Other Inherited or Acquired Anaemia, Other Rare Anaemias, Transfusional Iron Overload

Keywords

Haemoglobinopathies,, Myelodysplastic Syndromes,, Transfusional iron overload,, cardiac iron load

Brief summary

This study will evaluate the change in cardiac iron load over a 53 week period measured by MRI in 2 cohorts of patients

Interventions

DRUGdeferasirox

Deferasirox up to 40mg/kg/day, PO, Dispersible tablets, taken once daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female WITH haemoglobinopathy, Myelodysplastic Syndromes or other inherited or acquired anaemia (e.g. MPD, Diamond-blackfan anaemia and other rare anaemias) patients ≥ 18 years and weighing \>40kg. * Lifetime minimum of \> 20 units of packed red blood cell transfusions * Normal or minimally abnormal cardiac function

Exclusion criteria

* Contraindication to MRI scans * High risk myelodysplastic syndromes patients and patients with other haematological and non-haematological malignancies who are not expected to benefit from chelation therapy due to the rapid progression of their disease * Patients with uncontrolled high blood pressure * An organ transplant less than 3 months previously Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Change in cardiac iron load and cardiac ejection fraction by MRI recorded at baseline and after 53 weeks.	12 months

Secondary

Measure	Time frame
Change in ventricular ejection fraction values, ventricular volumes and masses from baseline values after 53 weeks.	12 months
Change in cardiac T2* from baseline to 53 weeks in the MDS and other anaemias subgroup, compared to the thalassaemia subgroup.	12 months
Changes in serum ferritin from baseline values to 53 weeks.	12 months
Changes in Liver Iron Content (LIC) by MRI from baseline values to 53 weeks	12 months
The relationship between the dosing regimen of Exjade® and changes in cardiac T2* and LIC R2 MRI	12 months
Changes in markers of iron load levels between baseline and 53 weeks.	12 months
The safety and tolerability of deferasirox therapy from baseline to 53 weeks	12 months

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026