Myelodysplastic Syndromes (MDS) Event Free Survival With Iron Chelation Therapy Study
Trial ID or NCT#
NCT00940602
Status
NOT RECRUITING
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
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Cancer Clinical Trials Office
650-498-7061
View on ClinicalTrials.gov
