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Myelodysplastic Syndromes (MDS) Event Free Survival With Iron Chelation Therapy Study
Not Recruiting
Trial ID: NCT00940602
Purpose
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)
Eligibility
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
Intervention(s):
drug: Deferasirox
drug: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061