Study of Association of Arsenic Trioxide (ATO) and Ascorbic Acid in Myelodysplastic Syndromes

You may be eligible if

• 1. Patients affected by myelodysplastic syndromes, entering in one of the following groups:
• 1. Myelodysplastic syndromes independent of WHO diagnostic classification (43) and IPSS prognostic score (2), when present at least one of the following abnormalities:
• * 3q26 chromosome rearrangement.
• * High EVI-1 transcript levels.
• 2. Myelodysplastic syndromes without excess of blasts (non-RAEB patients) at low or intermediate-1 score risk according to the IPSS (2), as a second line treatment option, after a failure to the first line treatment with erythropoietin +/- G-CSF, immunosuppressive therapy, or other initial treatment modality.
• 3. Non RAEB patients at intermediate-2 or high risk score or RAEB patients at any prognostic score, who are non candidate to treatment with conventional chemotherapy regimens.
• 2. Presence of one ore more cytopenias characterised by one ore more of the following elements:
• * Transfusions dependence.
• * Hb\< 11 gr/dl
• * Platelet count \< 50x109/L
• * Absolute neutrophil count \< .5x109/L.
• 3. ECOG Performance status ≤ 2.
• 4. Aged from 18 to 80.
• 5. Life expectancy \> 4 months.
• 6. Creatinine level \< 1.5 mg/dl.
• 7. Liver function tests, including ASL-ALT-alkaline phosphatase lower than 3xULN
• 8. No previous treatment with chemotherapy, growth factors, cytokines or other experimental treatment within 4 weeks of starting treatment.
• 9. No history of clinically significant cardiac disease, including congestive heart failure.
• 10. Cytogenetic evaluation available.
• 11. Sending of both peripheral blood and bone marrow sample to the central laboratory for EVI-1 rearrangement evaluation.
• 12. Written Informed consent.
• 2. Absence of cytopenia defined as the contemporarily presence of all the following conditions: a) no transfusion need; b) Hb \> 11 gr/dl; c) platelet count \> 50x109/L; d) absolute neutrophil count \> .5x109/L.
• 3. All patients that might be candidate to allogenic stem cell transplantation.
• 4. Patients that might be candidate to a first line immunosuppressive therapy.
• 5. ECOG Performance status \> 2.
• 6. Age lower than 18 or higher then 80.
• 7. Life expectancy \< 4 months.
• 8. Creatinine level \> 1.5 mg/dl.
• 9. Liver function tests, including ASL-ALT-alkaline phosphatase higher than 3xULN
• 10. Treatment with chemotherapy, growth factors, cytokines or other experimental treatment within 4 weeks of starting treatment.
• 11. Clinically significant cardiac disease, including congestive heart failure, rhythm abnormalities, QT time \> 460m/s, or need of anti-arrhythmic drugs.
• 12. Concurrent co-morbid medical condition which might exclude administration of therapy, as judged by individual investigator.
• 13. Absence of cytogenetic evaluation.
• 14. Participation at same time in another study in which investigational drugs are used.
• 15. Absence of written Informed consent.