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

Not Recruiting

Trial ID: NCT00940602


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

Stanford Investigator(s)

Jason Gotlib

Professor of Medicine (Hematology)


Inclusion Criteria:

   - 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:

   - 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


drug: Deferasirox

drug: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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