A One-year, Open-label, Single Arm, Multi-center Trial Evaluating the Efficacy and Safety of Oral ICL670 in Patients Diagnosed With Low and INT-1 Risk Myelodysplastic Syndrome (MDS) 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 feeding
Other protocol-defined inclusion/exclusion criteria may apply.