Inclusion Criteria:

1. Tumor type: Acute Myeloid Leukemia (AML) according to the WHO criteria (ea at least
20% blasts in the marrow). All FAB subtypes except M3. Patients with Myelodysplastic
Syndrome, category of Refractory Anemia with Excess Blasts (RAEB): RAEB I (WHO:
medullary blast count ≤ 10% and a peripheral blast count ≤ 5%) and RAEB II (WHO:
medullary blast count > 10% and/or > 5% peripheral blasts) can be included in the
study in absence of other non-experimental treatment modalities.

2. Extent of disease: remission (partial or complete) or smouldering course. Complete
remission (CR) is defined as no blasts in the peripheral blood and no more than 5%
blasts in the bone marrow. This definition is related to the hematological remission
if it is not specified. Partial remission (PR) is defined as a decrease of at least
50% in the percentage of blasts to 5 to 25% in the bone marrow aspirate. Smouldering
course is defined as a relatively low marrow blast count and slowly progressive
disease.

3. Overexpression of WT1 RNA (>50 copies of WT1 per 1000 copies ABL in bone marrow or >2
copy/1000 copies ABL in peripheral blood) as assessed by quantitative RT-PCR at the
time of presentation.

4. Prior treatments : Patients must have received at least one prior antileukemic
chemotherapeutic regimen and must be more than 1 month past the last treatment and/or
6 months past allogeneic/autologous stem cell transplantation.

5. Age: ≥ 18 years

6. High risk of relapse because of (and/or)

- Age > 60 years (if <60 y, no sibling allotransplant donor available)

- Poor risk cytogenetic or molecular markers at presentation

- Hyperleukocytosis at presentation

- Second complete remission after relapse

7. Performance status: WHO PS grade 0-1 (Appendix B)

8. Objectively assessable parameters of life expectancy: more than 3 months

9. Prior and concomitant associated diseases allowed with the exception of underlying
autoimmune disease and positive serology for HIV/HBV/HCV

10. No concomitant use of immunosuppressive drugs

11. Adequate renal and liver function, i.e. creatinin and bilirubin = 1.2 times the upper
limit of normal

12. Absence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule;
those conditions should be discussed with the patient before registration in the
trial

13. Women of child-bearing potential should use adequate contraception prior to study
entry and for the duration of study participation

Exclusion Criteria:

1. Subjects with concurrent additional malignancy (with exception of Non-melanoma skin
cancers and carcinoma in situ of the cervix)

2. Subjects who are pregnant

3. Subjects who have sensitivity to drugs that provide local anesthesia

4. Age < 18 years