Spots Global Cancer Trial Database for Decitabine Maintenance for Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS) Post Transplant

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Trial Identification

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

Official Title: Maintenance Therapy With Decitabine After Allogeneic Stem Cell Transplantation for Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome

Study ID: NCT00986804

Conditions

Leukemia, Myeloid, Acute

Myelodysplastic Syndromes

Interventions

Decitabine

Study Description

Brief 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.

Detailed 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.