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)

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

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.