More than 6 months of cumulative iron‐chelation therapy (such as daily deferasirox (Exjade) or deferiprone or 5x/week deferosamine). Intermittent deferoxamine doses in association with blood transfusions are not exclusionary regardless of duration of such treatment
More than 3 years since patient began receiving regular transfusions (2 units per 8 weeks or 4 units received in a 3 month period)
Creatinine clearance < 40 mL/min
Serum creatinine > 1.5x ULN at screening
Significant proteinuria: urinary protein/creatinine ratio > 0.5 mg/mg in a non first void urine sample
ECOG performance status > 2
Left ventricular ejection fraction < 55% by ECHO
History of hospitalization for congestive heart failure
Systemic disease that would prevent study treatment (uncontrolled hypertension, cardiovascular renal, hepatic or metabolic disease)
Hepatitis B or C (HBsAg in the absences or HBsAB or HCV Ab positive with HCV RNA positive)
History of HIV positivity (ELISA or Western blot)
Treatment with systemic investigational drug within 4 weeks or topical investigational drug within 7 days of study start
ALT or AST > 3.5 x ULN at screening
Total bilirubin > 1.5 x ULN at screening
Diagnosis of liver cirrhosis
Patient participating in another clinical trial or receiving an investigational drug
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
History of non‐compliance with medical regimen, or patients potentially unreliable or not cooperative
Presence of surgical or medical condition which might significantly alter the absorption, distribution , metabolism or excretion of study drug
Pregnant or intending to become pregnant or breast‐feeding patents
History of drug or alcohol abuse within the 12 months prior to enrolment.