MDS patients treated with deferasirox for transfusional iron overload

• Research type

  Research Study

• Full title

  A multi-centre, randomized, double-blind, placebo-controlled clinical trial of deferasirox in patients with myelodysplastic syndromes (low/int-1 risk) and transfusional iron overload (TELESTO)

• IRAS ID

  30649

• Contact name

  Sally Killick

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2009-012418-38

• ISRCTN Number

  Not submitted

• Research summary

  This study will evaluate the use of deferasirox (Exjade) or placebo in adult patients with low or intermediate-1 myelodysplastic syndromes (MDS) who are dependent on blood transfusions. MDS is a bone marrow disorder in which the blood cell numbers in the circulation are reduced, and many require blood transfusions to treat the anaemia. It is thought that iron accumulated from multiple transfusions causes harm to the body organs, in particular the heart and liver. This study aims to document the effects of desferasirox or placebo on iron accumulation (event free survival).About 630 patients will join in this study at approximately 122 centers from around the world. Patients will be asked to come into hospital once every month for up to 5 years. Each visit is anticipated to take about 1 hour or less. This is sponsored by the pharmaceutical company named Novartis.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  09/H0720/133

• Date of REC Opinion

  7 Jan 2010

• REC opinion

  Further Information Favourable Opinion