drugset / Trial / NCT01541280

VIDAZA-DLI Pre-emptive Azacitidine and Donor Lymphocyte Infusions Following Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Acute Myeloid Leukemia and Myelodysplastic Syndrome

NCT01541280 ↗

Phase 2 Completed 30 enrolled Nantes University Hospital
NaSingle-groupOpen-labelTreatment

Summary

Patients included in the study with high risk acute myeloid leukemia or myelodysplastic syndrome as defined will receive an allogeneic transplantation conditioned by either myeloablative or reduced regimen. Following allogeneic transplantation, patients will receive a maintenance regimen combining chemotherapy with azacitidine (aza) and immunotherapy with donor lymphocyte infusion.

Timeline

Start
2011-11
Primary completion
2015-07
Completion
2015-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 32 mg/m2 Subcutaneous