A Phase II Study of the Use of 5-Azacytidine as Pre-Transplant Cytoreduction Prior to Allogeneic Stem Cell Transplantation for High Risk Myelodysplastic Syndromes
The study drug, 5-azacytidine, is given daily intravenously for 7 days. After every 2
cycles study participants will have a bone marrow test to evaluate the effect of the
5-azacytidine on the Myelodysplastic Syndrome (MDS). Participants continue to get cycles of
5-Azacytidine until 2 bone marrow tests show the MDS has stopped responding to the
treatment. At that time they will undergo a transplant if a donor is available.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
1 year and 2-year event free and overall survival (EFS and OS) from the time of transplant.
John M. McCarty, MD
Virginia Commonwealth University
United States: Institutional Review Board
|Massey Cancer Center / Virginia Commonwealth University||Richmond, Virginia 23298|