De-Iron

De-Iron: A phase 2 study of the efficacy and safety of Deferasirox administered at early iron loading in patients with transfusion-dependent Myelodysplastic Syndromes

Trial Overview and Summary

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Myelodysplastic Syndromes (MDS) cause a failure of the bone marrow, which does not produce enough blood cells (red cells, white cells and platelets). This is because the bone marrow contains too many abnormal cells (dysplastic cells) which function poorly.

Many patients with MDS, do not produce enough red blood cells, which leads to anaemia. This means that they receive regular blood transfusions to treat the anaemia and alleviate symptoms. However, blood is rich in iron and repeated transfusions may cause a buildup

of excess iron. Although iron is an essential part of the blood, an excess of iron may affect the way the organs in the body function. This includes the liver and heart. This situation is called iron overload. The aim of this study is test how effective, safe and tolerable a drug called Deferasirox (also called Exjade®) is, when used to treat rising iron levels, in patients with MDS.

Please note that the trials team cannot give individual’s clinical advice. Patients and their families should contact their treating physician to discuss trials for which they may be eligible

Chief Investigator:  Dr Dominic Culligan
Sponsor:  University of Birmingham
Funders:  Bloodwise (Non-TAP)
Disease Site:  Myelodysplastic Syndromes
Trial Type:  Clinical Trial of an Investigational Medicinal Product
Status:  In Follow up
UKCRN Study ID: (if applicable)  

13706

Open to new sites?  No
Recruitment start date:  19-Jun-2013
Recruitment end date  30-Nov-2015
CRCTU Trial Management Team:  Haematology
Trial E-mail Address:  de-iron@trials.bham.ac.uk

Trial Protocol

Please Note:

Clinical trial protocols are complex technical documents which should only be used for the treatment of subjects taking part in the trial. Patients who are interested in taking part in the trial are advised to talk to their health care professional or refer to CancerHelp website.

Investigators please ensure you have R&D approval for this specific version of the protocol before using as a reference.