25
Participants
Start Date
March 31, 2008
Primary Completion Date
December 31, 2013
Study Completion Date
June 30, 2014
5-azacitidine
Once enrolled, the patients will receive pre-transplant 5-azacitidine (Vidaza) 75 mg/M\^2/day subcutaneously for 5-7 days every 28 days). Adjustments in dose and timing may occur based on clinical and hematological parameters.
Allogeneic Hematopoietic Cell Transplantation (HCT)
"Patients will receive transplantation if there is either a suitable sibling or an unrelated donor.~* Response will be evaluated by bone marrow biopsy after 4 cycles of 5-azacitidine or prior to HCT whichever comes first. Due to the very high risk of progression to AML or death in this patient population, the HCT will be done as soon as possible.~* The patients may have additional cycles of 5-azacitidine per standard hematology practice until scheduled for transplant or until progression of disease.~* All patients will be followed until time to progression of MDS, AML or death or a maximum of 1 year. For patients that are transplanted, follow up will be to one year post-transplant."
H. Lee Moffitt Cancer Center & Research Institute, Tampa
Collaborators (1)
Celgene Corporation
INDUSTRY
H. Lee Moffitt Cancer Center and Research Institute
OTHER