An Open-label, Phase II, Randomized, Pilot Study to Assess the Effect in Term of Erythroid Improvement of Deferasirox Combined With Erythropoietin Compared to Erythropoietin Alone 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 < 2 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 > 6 g/dL (no RBC transfusions are allowed during study)

- History of transfusions < 10 RBC units

- 300 ng/mL < serum ferritin < 1,000 ng/mL

- 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 (prophylactic hydrocortisone to prevent transfusion
reaction, steroid for adrenal failure, and intermittent dexamethasone as antiemetic
are allowed).

- B12 and folate deficient patients (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.