Study of Deferasirox for Treatment of Transfusional Iron Overload in Myelodysplastic Patients

Inclusion Criteria: * Male or female patients with low or intermediate (INT-1) risk MDS * Patients can be EITHER naïve to iron chelation OR have had prior treatment with deferoxamine (DFO). * Age greater than or equal to 18 years * Availability of transfusion records for the 12 weeks prior to registration * A lifetime minimum of 30 previous packed red blood cell transfusions * Availability of at least three CBC values (pretransfusion) during the 12 weeks prior to registration * Serum Ferritin: For entry into the screening period, serum ferritin ≥ 1000 ng/mL on at least two occasions, at least two weeks apart, during the prior year. Serum ferritin ≥ 1000 ng/mL at screening via the central lab. * Life expectancy ≥ 6 months * Sexually active women must use an effective method of contraception, or must have undergone clinically documented total hysterectomy and/or oophorectomy, or tubal ligation or be postmenopausal (defined as amenorrhea for at least 12 months) * Able to provide written informed consent Exclusion Criteria: * Serum creatinine above the upper limit of normal * Alanine aminotransferase (ALT) \> 500 U/L during screening * Clinical or laboratory evidence of active Hepatitis B or C * Urinary protein/creatinine ratio \> 0.5 mg/mg * History of HIV positive test result (ELISA or Western blot) * Eastern Cooperative Oncology Group (ECOG) Performance Status \> 2 * Patients with uncontrolled systemic hypertension * Unstable cardiac disease not controlled by standard me…