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6 administration every 2 weeks of intra-muscular 200 micrograms of protein recwt1-A10+AS01B at week 1, 3, 5, 7, 9 and 11.

recwt1-A10+AS01B

Didier BLAISE, MD PhD

Patients with acute or chronic myeloid leukemia, or myelodysplastic syndrome, underwent allogeneic stem cell transplantation from HLA-identical donor (related or unrelated) after reduced-intensity conditioning regimen.

If WT1 expression is detectable on tumor cells, they will receive an immune therapy 60 days after allograft.

6 administrations every 2 weeks of the protein recwt1-A10+AS01B will be administrated.

The safety and immunological efficacy of this immune therapy after hematopoietic stem cells transplantation with reduced intensity conditioning will be evaluated.

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

Etude Phase I/II d'immunothérapie Par protéine recWT1-A10+AS01B après Greffe allogénique de Cellules Souches

Dose limit toxicity (adverse event according to CTCAE V4.0)

The specific WT1 antibody induced by the vaccination will be evaluated by the technic ELISA in UE/ml.

Institut Paoli-Calmettes

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase I/II Study of Immune Therapy After Allograft in Patients With Myeloid Hemopathy	NCT01819558	Acute Myeloid L... Chronic Myeloid... Myelodysplastic...	recwt1-A10+AS01...	18 Years - 65 Years	Institut Paoli-Calmettes
Phase I/II Study of Immune Therapy After Allograft in Patients With Myeloid Hemopathy	NCT01819558	Acute Myeloid L... Chronic Myeloid... Myelodysplastic...	recwt1-A10+AS01...	18 Years - 65 Years	Institut Paoli-Calmettes

Spots Global Cancer Trial Database for wt1 expression