Pre-emptive Azacitidine and Donor Lymphocyte Infusions Following Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Acute Myeloid Leukemia and Myelodysplastic Syndrome
- 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
- 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.
- The presence of any one exclusion criteria renders the patient ineligible:
- Patient in full relapse post-transplant (>20% blasts in the bone marrow) following
- 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
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