WT1 Immunity Via DNA Fusion Gene Vaccination in Haematological Malignancies by Intramuscular Injection Followed by Intramuscular Electroporation

Inclusion Criteria:

* CML patients:

Philadelphia chromosome positive CML in chronic phase, in complete cytogenetic response (CCyR) but with detectable BCR-ABL transcripts and maintained the CCyR on imatinib monotherapy for a minimum of 24 months

AML patients:

WT1+ AML in CR or morphologic CR with incomplete blood count recovery (CRi);

All patients:

* ≥ 18 years of age, written informed consent
* Performance status of 0 or 1.
* for vaccination groups: HLA-A0201 positive in at least one allele
* for control groups: HLA A2 negative in both alleles
* renal function and liver function (Creatinine \<1.5 x upper limit of normal, liver function tests \< 1.5 x upper limit of normal); Lymphocyte count \> 1.0 x109/l; normal clotting
* HB\>100 g/l
* Adequate venous access for repeated blood sampling according to protocol schedule.
* If sexually active and possibly fertile, patients must agree to use appropriate contraceptive methods during the trial and for six months afterwards.

Exclusion Criteria:

* CML patients:

  * CML in accelerated phase or blast crisis or having achieved CMR at any point during imatinib therapy.
  * Imatinib dose modification in the previous year, Imatinib interruption for more than 15 days in the previous 6 months to enrolment
  * Prior interferon-α therapy
  * hypocellular bone marrow (\<20%)
  * Complete molecular response (CMR)

AML patients:

* AML in haematological relapse or eligible for allogeneic SCT.
* hypocellular bone marrow (\<20%)
* AML patients with the "good-risk" abnormalities comprised by the core binding factor leukaemias (i.e., AML with the translocation (8;21) and inversion of chromosome 16, and acute promyelocytic leukaemia with the translocation (15;17))

All patients:

* Systemic steroids or other drugs with a likely effect on immune competence are forbidden during the trial. The predictable need of their use will preclude the patient from trial entry
* Major surgery in the preceding three to four weeks from which the patient has not yet recovered.
* Patients who are of high medical risk because of non-malignant systemic disease, as well as those with active uncontrolled infection.
* Patients with any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial, such as concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/ IV cardiac disease
* Current malignancies at other sites, with the exception of adequately treated basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for five years and are deemed at low risk for recurrence, are eligible for the study.
* Patients who are serologically positive for or are known to suffer from Hepatitis B, C, Syphilis or HIV. Counselling will be offered to all patients prior to testing.