Myelodysplastic Syndromes Clinical Trial
Official title:
Maintenance Therapy With Decitabine After Allogeneic Stem Cell Transplantation for Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome
Primary:
To determine the maximum tolerated dose and schedule of decitabine when administered as
maintenance therapy after allogeneic hematopoietic stem cell transplantation (alloHSCT)
performed for AML or high-risk MDS.
Secondary:
- To determine the safety and tolerability of decitabine as maintenance therapy after
alloHSCT.
- To determine the rates disease relapse, 1-year disease-free survival, and overall
survival.
- To assess lymphoid and myeloid chimerism while on decitabine maintenance.
- To determine the incidence of acute and chronic GVHD.
- To assess immunologic reconstitution after alloHSCT.
- To assess changes in gene expression and methylation patterns following decitabine
treatment
- To assess the effects of decitabine on immune reconstitution post transplant.
- To access the frequency of FoxP3+ CD3+/CD4+ and CD3+/CD8+ lymphocytes before and after
decitabine treatment.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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