Decitabine Maintenance for Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS) Post Transplant

2014-08-27 03:18:58 | BioPortfolio



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.

Study Design

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
St. Louis
United States




Washington University School of Medicine

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:18:58-0400

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Medical and Biotech [MESH] Definitions

A pediatric acute myeloid leukemia involving both myeloid and monocytoid precursors. At least 20% of non-erythroid cells are of monocytic origin.

A rare acute myeloid leukemia characterized by abnormal EOSINOPHILS in the bone marrow.

An acute myeloid leukemia in which abnormal PROMYELOCYTES predominate. It is frequently associated with DISSEMINATED INTRAVASCULAR COAGULATION.

An acute leukemia exhibiting cell features characteristic of both the myeloid and lymphoid lineages and probably arising from MULTIPOTENT STEM CELLS.

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