Safety, Tolerability, and Efficacy of Deferasirox in MDS

Inclusion Criteria: * Patients, both males and females, with low and intermediate I risk (IPSS score) Myelodysplastic syndrome and transfusion-induced hemosiderosis. * Age \>=18 years * Patients who never received chelation therapy or who received a therapy with Desferal after a day of wash out * Medical history of at least 20 blood transfusions (equivalent to 100 ml/kg of red cells concentrate). * Availability of data concerning blood transfusions during the 12 weeks before screening * Serum ferritin \>= 1000 µg/L at least twice (at least 2 week interval between the 2 analysis) during the year before the screening * Life expectancy \> 12 months * Availability of at least 3 complete blood counts (before transfusions) during the 12 weeks before the screening Exclusion Criteria: * Diagnosis different from MDS (i.e. myelofibrosis) * Severe renal impairment (creatinine clearance \< 60 ml/min) * ALT/AST \> 500 U/L * Active B and/or C hepatitis * Patients treated during the past 4 weeks with experimental drugs for MDS (including thalidomide, azacitidine, arsenic trioxide). These patients become eligible after a "wash out" of at least 4 weeks * Concomitant treatment with another iron-chelating agent