Prospective Phase II Study of Decitabine Induction Therapy to Reduce Pre-transplant Disease Burden Prior to Allogeneic Hematopoietic Cell Transplant in Patients With Newly Diagnosed Myelodysplastic Syndromes.
1. safety and tolerability of Decitabine prior to transplant (assessed by occurence of
non-hematologic toxicities of grade 3 or more as defined by CTC grading)
2. reduction in pre-transplant disease burden ability to achieve blast <5% in the bone
marrow and peripheral blood
1. Proportion of patients with suitable donor able to proceed to an allogeneic
hematopoietic cell transplant.
2. Non-relapse mortality
3. time to neutrophil engraftment
4. Overall survival and disease-free survival.
Patients will receive Decitabine until blast <5% is achieved, suitable HLA-matched donor or
umbilical cord blood is available up to a maximum of 6 cycles. Patient who progress on
therapy or are unable to find a donor by 6 cycles will be removed from protocol. The
method, conditioning regimen and choice of donor will be determined based on patient's age
and functional status, and transplant physician's discretion. The available regimens are
standardized within the center
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Reduction in pre-transplant disease burden
Singapore General Hospital
Singapore: Health Sciences Authority