This study is designed as a multicenter trial, with biological assignment to one of two
study arms; Arm 1: Reduced intensity conditioning allogeneic hematopoietic cell
transplantation (RIC-alloHCT), Arm 2: Non-Transplant Therapy/Best Supportive Care.
Background: MDS is a clonal disorder of hematopoietic precursors and stem cells, which may
evolve to a terminal phase resembling acute leukemia. A subject of clinical urgency for
researchers, clinicians, patients, and health care underwriters such as Medicare, is the
role of allogeneic hematopoietic cell transplantation (alloHCT) in the treatment of older
patients with higher risk myelodysplastic syndromes (MDS). The use of reduced intensity
conditioning (RIC) regimens has extended HCT to the care of older patients with acute
myelogenous leukemia (AML) and lymphoma and a number of retrospective and phase II trials
for patients with MDS now show the curative potential of RIC alloHCT in selected patients.
This protocol is designed to evaluate the relative benefits of RIC alloHCT compared to
non-transplant therapies focusing on overall survival. This will be done by having
patients biologically assigned to the alloHCT arm or the hypomethylating therapy/best
supportive care arm and following them for survival at 3 years.