VIDAZA-DLI Pre-emptive Azacitidine and Donor Lymphocyte Infusions Following Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Acute Myeloid Leukemia and Myelodysplastic Syndrome

Inclusion Criteria:

* Patients with high risk acute myeloid leukemia undergoing allogeneic transplantation with either a familial or an unrelated donor.

High risk AML is defined as :

* AML in CR1 with unfavorable cytogenetics defined by complex caryotype, autosomal monosomy combined or not with other cytogenetics abnormalities inv(3)/t(3,3), t(6;9), t(6;11), t(11;19), del(5q), del(7q).
* AML in CR2 or greater remission prior allogeneic transplantation
* AML in PR or relapse prior allogeneic transplantation
* Or Patients with high risk myelodysplastic syndrome undergoing allogeneic transplantation with either a familial or an unrelated donor.

High risk MDS is defined as :

* MDS with intermediate-2 group and higher risk group according to IPSS criteria
* Age 18 - 70 years.
* Availability of an HLA identical family donor or unrelated donor with matching in 10/10 alleles (HLA-A, B, C, DRB1, DQB1) or maximum of 1 allele or antigen mismatch OR family donor with maximum 1 allele mismatch.
* Conditioning regimen to allogeneic transplantation may be either myeloablative or reduced.
* Be able to understand and sign informed consent.
* Affiliation number to National Health Care System
* Men and women of childbearing potential must use effective contraception during and up to 3 months after treatment.

Exclusion Criteria:

* The presence of any one exclusion criteria renders the patient ineligible:
* Patient in full relapse post-transplant (\>20% blasts in the bone marrow) following allogeneic transplant
* Documented leukemic infiltration of CNS/cerebrospinal fluid.
* Karnofsky performance score below 60%.
* Acute and chronic heart failure (NYHA Class III or IV) or symptomatic ischemic heart disease.

following allogeneic transplant

* Severe liver failure (bilirubin \>30 μmoles/L, SGPT \> 4 X upper limit of normal).
* Hepatic malignancy in advanced stage.
* Severe neurological or psychiatric disorders
* Acute GVHD grade II-III. Patient with grade I GVHD may be included (see annex 1 for GHVD grade definition).
* Active uncontrolled infection.
* Denied informed consent.
* Treatment with other investigational drugs following allogeneic transplantation.
* No effective contraception
* Lactating females
* Pregnant woman