Phase I/II Study of Immune Therapy After Allograft in Patients With Myeloid Hemopathy

Inclusion criteria

• Patients older than 18 and younger than 65 years.
• Karnofsky ≥ 70 %.
• Patients with acute or chronic myeloid leukemia, or myelodysplastic syndrome, who underwent allogeneic stem cell transplantation from HLA-identical donor (related or unrelated) after reduced-intensity conditioning regimen.
• Patients in morphologic complete remission at the time of transplantation.
• WT1 expression detectable on tumor cells.
• Expected life duration more than 6 months.
• Creatinine clearance ≥ 50 ml/min
• Bilirubinemia < 1.5N and ASAT < 2.5N.
• Women of childbearing age: negative pregnancy test and effective contraception for at least 30 days before vaccinal immunotherapy (the same contraceptive method must be continued at least 2 months after the last vaccine infusion).
• Membership of a social security scheme or beneficiary of such a regime.
• Signed inform consent.

Exclusion criteria

• Patients with severe and uncontrolled affections, especially active graft-versus-host disease requiring steroid treatment (>0.3 mg/kg/j) and/or Mycophenolate mofetil.
• Pregnant or lactating women.
• HIV seropositive patients.
• Autoimmune disease (Lupus, multiple sclerosis, Chron disease…)
• Previous history of allergic state which could be potentially compound by a component of the vaccinal immunotherapy.
• Patients who received (or are planned to receive) another experimental treatment within 30 days following the first infusion of the experimental drug of this protocol.
• Previous history of another cancer, except if considered as probably cured by the investigator.
• Patients deprived of liberty, or under guardianship.