Combination Study of Deferasirox and Erythropoietin in Patients With Low- and Int-1-risk Myelodysplastic Syndrome.

Inclusion Criteria:

- Patients with low- and Int-1-risk myelodysplastic syndrome

- Documented diagnosis of the following:

Myelodysplastic syndrome lasting ≥ 3 months and < 3 years Disease must not be secondary to
treatment with radiotherapy, chemotherapy, and/or immunotherapy for malignant or
autoimmune diseases

- A hemoglobin < 10 g/dL and ≥ 8 g/dL

- History of transfusions < 10 RBC units and must not be RBC transfusion dependent

- 300 ng/mL < serum ferritin < 1,500 ng/mL (Values within 10% difference above 1500
ng/ml or 10% difference below 300 ng/ml may be accepted at the investigator's
discretion.

- Endogenous erythropoietin levels < 500 units/L

Exclusion Criteria:

- Patients with MDS with isolated del(5q)

- Patients who had received prior EPO treatment or other recombinant growth factors
regardless of the outcome (Patient who had received prior EPO treatment or other
recombinant growth factors for less than 4 weeks and not within 3 months before
screening without a documented response are allowed)

- Patients receiving steroids or immunosuppressive therapy for the improvement of
hematological parameters (stable steroid treatment for adrenal failure or chronic
medical conditions, and intermittent dexamethasone as antiemetics are allowed).

- B12 and folate deficient patients with and without clinical symptoms (patients could
be rescreened after successful therapy of B12 and folate deficiency)

- Uncontrolled seizures or uncontrolled hypertension

Other protocol-defined inclusion/exclusion criteria may apply.