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)
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Haemoglobinopathies,, Myelodysplastic Syndromes,, Other Inherited or Acquired Anaemia (e.g. MPD, Diamond-blackfan Anaemia and Other Rare Anaemias),, Transfusional Iron Overload
Both
Haemoglobinopathies,, Myelodysplastic Syndromes,, Other Inherited or Acquired Anaemia (e.g. MPD, Diamond-blackfan Anaemia and Other Rare Anaemias),, Transfusional Iron Overload
Trial Information
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)
Inclusion Criteria
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/exclusion criteria may apply.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Change in cardiac iron load and cardiac ejection fraction by MRI recorded at baseline and after 53 weeks.
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmeceuticals
Authority:
Australia: Therapeutic Goods Administration
Study ID:
CICL670AAU01
NCT ID:
NCT00673608
Start Date:
November 2007
Completion Date:
September 2011
Related Keywords:
- Haemoglobinopathies,
- Myelodysplastic Syndromes,
- Other Inherited or Acquired Anaemia (e.g. MPD, Diamond-blackfan Anaemia and Other Rare Anaemias),
- Transfusional Iron Overload
- Haemoglobinopathies,
- Myelodysplastic Syndromes,
- Transfusional iron overload,
- cardiac iron load
- Anemia
- Hemoglobinopathies
- Myelodysplastic Syndromes
- Preleukemia
- Iron Overload
- Anemia, Diamond-Blackfan
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