5-Azacytidine Prior to Allogeneic Stem Cell Transplant in High Risk Myelodysplastic Syndrome
Patients with high risk myelodysplastic syndrome (MDS) responding to 5-azacytidine prior to allogeneic transplant have improved event free and overall survival.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 1 year and 2-year event free and overall survival (EFS and OS) from the time of transplant. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Secondary endpoints will include intent to treat analysis of 1-year and 2-year EFS and OS for all patients receiving 5-Azacytidine from the time of initial therapy as well as engraftment of WBC and platelets, graft failure, relapse and GVHD. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days.
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.
|United States, Virginia|
|Massey Cancer Center / Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Study Chair:||John M. McCarty, MD||Virginia Commonwealth University|