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

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

Summary

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.

Description

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Leukemia, Myeloid, Acute

Intervention

Decitabine 5 mg/m2/day, Decitabine 7.5mg /m2/day, Decitabine 10 mg/m2/day

Location

Washington University School of Medicine
St. Louis
Missouri
United States
63110

Status

Recruiting

Source

Washington University School of Medicine

Results (where available)

View Results

Links

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.

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