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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.
- 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: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Leukemia, Myeloid, Acute
Decitabine 5 mg/m2/day, Decitabine 7.5mg /m2/day, Decitabine 10 mg/m2/day
Washington University School of Medicine
Washington University School of Medicine
Published on BioPortfolio: 2014-08-27T03:18:58-0400
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A pediatric acute myeloid leukemia involving both myeloid and monocytoid precursors. At least 20% of non-erythroid cells are of monocytic origin.
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