|Exclusion Criteria:||1) More than 3 years since patient began receiving regular transfusions (2 units per 8 weeks or 4 units received in a 3 month period).|
2) Creatinine Clearance <40 ml/min
3) Serum creatinine > 1.5 x ULN at screening
4) Significant proteinuria as indicated by a urinary protein/creatinine ratio > 0.5 mg/mg in a non-first void urine sample at Visit 1 or Visit 2 (or alternatively in two of three samples obtained for screening).
5) ECOG performance status > 2.
6) Left ventricular ejection fraction < 50% by echocardiography as per the central reading assessment.
7) A history of hospitalization for congestive heart failure.
8) Systemic diseases which would prevent study treatment (e.g.uncontrolled hypertension, cardiovascular, renal, hepatic, metabolic, etc.).
9) Clinical or laboratory evidence of active Hepatitis B or Hepatitis C (HBsAg in the absence of HBsAb OR HCV Ab positive with HCV RNA positive).
10) History of HIV positive test result (ELISA or Western blot).
11) Treatment with systemic investigational drug within 4 weeks or topical investigational drug within 7 days of study start.
12) ALT or AST > 3.5 × ULN at screening.
13) Total bilirubin > 1.5 x ULN at screening.
14) Diagnosis of liver cirrhosis (either established diagnosis or diagnosis by liver biopsy or central ultrasound reading).
15) Patients participating in another clinical trial other than an observational registry study.
16) Patients with a history of another malignancy within the past five years, with the exception of basal skin carcinoma or cervical carcinoma in situ or completely resected colonic polyps carcinoma in situ.
17) History of non-compliance to medical regimens, or patients who are considered potentially unreliable and/or not cooperative.
18) Presence of a surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drug.
19) Pregnant, intending-to-become pregnant, or breast-feeding patients.
20) History of drug or alcohol abuse within the 12 months prior to enrollment.
21) More than 6 months of cumulative iron chelation therapy (such as daily deferasirox (Exjade) or deferiprone or 5x/week deferoxamine
22) Intermittent deferoxamine doses in association with blood transfusions are not exclusionary regardless of duration of such treatment.