drugset / Trial / NCT01390311

Azacitidine After Chemotherapy and Donor Lymphocyte Infusion in Patients With Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome Previously Treated With Donor Stem Cell Transplant

NCT01390311 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

This phase I trial studies the effects and safety of adding azacitidine (5-AzaC) to the standard of care (Soc) for patients with relapsed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after being treated with donor stem cell transplant. SoC includes giving an infusion of the donor's white blood cells (donor lymphocyte infusion or DLI) to boost the anticancer effects of the transplant. Giving 5-AzaC after DLI may alter the function of T-cells resulting in reduced incidence of graft versus host disease (GVHD) while maintaining the anticancer effects.

Timeline

Start
2012-04
Primary completion
2014-03
Completion
2015-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 45 mg/m2 Intravenous
Subject Azacitidine Other / unclassified 75 mg/m2 Intravenous