GFM-Acadesine: A Phase I-II Trial of Acadesine

Inclusion Criteria: * Myelodysplastic syndrome including the following WHO categories: refractory anemia with excess blasts (RAEB), non-proliferative chronic myelomonocytic leukemia (CMML) (leukocytes \< 13 G/L but \> 10% marrow blasts), WHO- AML with 20-30% marrow blasts (RAEB-T according to the FAB classification) * Prior treatment with Azacitidine or Decitabine for at least 6 courses without response (including CR, PR, marrow CR and stable disease with hematological improvement) or relapse after a response * IPSS score \>1 (IPSS: Int-2 or High); * Age ≥ 18 years; * Normal liver function tests, defined by total bilirubin and transaminases less than 1.5 time the upper limit of normal; * Normal renal function, defined by creatinine less than 1.5 time the upper limit of normal, creatinine clearance ≥ 50 mL/min. * Patient ineligible for allogeneic hematopoietic stem cell transplantation; * Written informed consent; * Patient must understand and voluntarily sign consent form; * Patient must be able to adhere to the visit schedule as outlined in the study and follow protocol requirements; * ECOG performance status between 0-2 at the time of screening; * Women of childbearing potential must: Agree to use effective contraception without interruption throughout the study and for a further 1 month after the end of treatment; * Men must: Agree to not conceive during the treatment and to use effective contraception during the treatment period (including periods of dose reduction or temporary suspension) and for a further 1 month after the end of treatment if their partner is of childbearing potential. Exclusion Criteria: * Severe infection or any other uncontrolled severe condition * Significant cardiac disease - NYHA Class III or IV or having suffered a myocardial infarction in the last 6 months * Less than 30 days since prior treatment with growth factors (EPO, G-CSF) * Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea. The patient must have recovered from all acute toxicities from any previous therapy. * Active cancer, or cancer during the year prior to trial entry other than basal cell carcinoma or carcinoma in situ of the cervix or breast; * Patient already enrolled in another therapeutic trial of an investigational drug; * HIV infection or active hepatitis B or C; * Women who are or could become pregnant or who are currently breastfeeding; * Any medical or psychiatric contraindication that would prevent the patient from understanding and signing the informed consent form; * Patient eligible for allotransplantation. * Known allergy to acadesine or any of its excipients * No affiliation to an insurance system