Study of Decitabine Induction Prior to Allogeneic Hematopoietic Cell Transplant in Newly Diagnosed MDS Patients
Status:
Terminated
Trial end date:
2013-08-01
Target enrollment:
Participant gender:
Summary
Allogeneic blood stem cell transplant remains the only potential curative treatment for
myelodysplastic syndromes (MDS) to date. Pre-transplant induction chemotherapy with
leukemia-type regimens is associated with significant toxicity and even death. The
hypomethylating agents decitabine and 5-azacytidine have been shown in studies to cause
improved hematologic parameters and partial or complete responses in patients with high risk
MDS compared to standard therapy. In contrast to leukemia-type chemotherapy, decitabine is
associated with a relatively low risk of toxicity. We therefore propose to treat
transplant-eligible MDS patients with Decitabine as induction therapy and a bridge to
transplant.
Hypothesis:
1. Decitabine is able to reduce disease burden as measured by blood and marrow blast counts
prior to allogeneic hematopoietic stem cell transplant to below 5%.
2. Decitabine is well-tolerated by patients with high-risk MDS and will be a safe induction
agent and bridge prior to allogeneic transplant in transplant-eligible patients.