drugset / Trial / NCT01819558

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

NCT01819558 ↗

Phase 1/2 Completed 2 enrolled Institut Paoli-Calmettes
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2013-03
Primary completion
2015-03
Completion
2015-03

Drugs

EvaluationDrugModalityDoseRoute
Subject recwt1-A10+AS01B Protein / enzyme biologic 200 ug Intramuscular