Myelodysplastic Syndromes (MDS) Event Free Survival With Iron Chelation Therapy Study

Trial ID or NCT#



not recruiting iconNOT RECRUITING


This was a randomized, double-blind trial to evaluate deferasirox vs placebo in patients with myelodysplastic syndromes (low/int-1 risk) and transfusional iron overload .The trial was conducted in 17 countries, started in 2010 and ended in 2018.

Official Title

A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial of Deferasirox in Patients With Myelodysplastic Syndromes (Low/Int-1 Risk) and Transfusional Iron Overload

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Weigh between 35-135 kilograms - Low or int-1 risk MDS - Ferritin >1000 micrograms/liter at screening - History of transfusion of 15 to 75 Packed Red Blood Cells (PRBC) units - Anticipated to be transfused with at least 8 units of PRBCs annually during the study - Women of child-bearing potential using effective methods of contraception during dosing of study treatment
Exclusion Criteria:
  1. - More than 6 months of cumulative ICT (such as daily deferasirox (Exjade®) or deferiprone or 5×/week deferoxamine) - More than 3 years since patient began receiving regular transfusions (2 units per 8 weeks or 4 units received in a 3 month period) - Significant proteinuria - History of hospitalization for congestive heart failure; other heart conditions as specified in the protocol - Systemic diseases which would prevent study treatment - Hepatitis B; Hepatitis C; HIV - Liver cirrhosis - Pregnant, or breast-feeding patients, or patients of child-bearing potential not employing an effective method of birth control - History of drug or alcohol abuse within the 12 months prior to enrollment


Jason Gotlib
Hematologist, Medical oncologist, Leukemia specialist, Hematologist-Oncologist
Professor of Medicine (Hematology)

Contact us to find out if this trial is right for you.


Cancer Clinical Trials Office