Efficacy and Safety of Deferasirox in Patients With Myelodysplastic Syndrome and Transfusion-dependent Iron Overload

Inclusion Criteria: * MDS patients presenting with low or intermediate-1 IPSS risk and transfusional iron overload * Patients of either gender and age ≥ 18 years * History of at least 20 units of red blood cell transfusions or 100mL/kg of prepacked red blood cells (PRBCs) * Patients can be either naïve to iron chelation or have had prior treatment with deferoxamine (DFO) or deferiprone (L1) * Females of childbearing potential must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation or be postmenopausal defined by amenorrhea for at least 12 months. Exclusion Criteria: * Non-transfusion related iron overload * Treatment with deferasirox (ICL670) before study start * Patients with a concomitant malignant disease * Patients with out of range lab values * History of nephrotic syndrome * Patients with a previous history of clinically relevant ocular toxicity related to iron chelation * Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent the patient from undergoing study treatment * Patients treated with systemic investigational drugs within the past 4 weeks or topical investigational drug within the past 7 days * Any other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug. * Patients with active uncontrolled infectious disease * Pregnancy or breast fe…