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

Myelodysplastic Syndromes Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00673608
• Other study ID #: CICL670AAU01
• Status: Completed
• Phase: Phase 4
• First received: May 5, 2008
• Last updated: February 20, 2017
• Start date: November 2007
• Est. completion date: September 2011

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• deferasirox
Deferasirox up to 40mg/kg/day, PO, Dispersible tablets, taken once daily

Locations

Country	Name	City	State
Australia	Novarts Investigative Site	Adelaide
Australia	Novarts Investigative Site	Brisbane
Australia	Novarts Investigative Site	Melbourne
Australia	Novarts Investigative Site	Sydney

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Australia, 

Outcome

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

External Links

•   Results for CICL670AAU01 from the Novartis Clinical Trials website