Etude Phase I/II d'immunothérapie Par protéine recWT1-A10+AS01B après Greffe allogénique de Cellules Souches
1. Patients older than 18 and younger than 65 years.
2. Karnofsky ≥ 70 %.
3. 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.
4. Patients in morphologic complete remission at the time of transplantation.
5. WT1 expression detectable on tumor cells.
6. Expected life duration more than 6 months.
7. Creatinine clearance ≥ 50 ml/min
8. Bilirubinemia < 1.5N and ASAT < 2.5N.
9. 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).
10. Membership of a social security scheme or beneficiary of such a regime.
11. Signed inform consent.
1. Patients with severe and uncontrolled affections, especially active graft-versus-host
disease requiring steroid treatment (>0.3 mg/kg/j) and/or Mycophenolate mofetil.
2. Pregnant or lactating women.
3. HIV seropositive patients.
4. Autoimmune disease (Lupus, multiple sclerosis, Chron disease…)
5. Previous history of allergic state which could be potentially compound by a component
of the vaccinal immunotherapy.
6. Patients who received (or are planned to receive) another experimental treatment
within 30 days following the first infusion of the experimental drug of this
7. Previous history of another cancer, except if considered as probably cured by the
8. Patients deprived of liberty, or under guardianship.