NCT00986804

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	Decitabine

Timeline

• Start date: 2009-12-01
• Primary completion: 2014-05-01
• Completion: 2016-02-01
• First posted: 2009-09-30
• Last updated: 2016-02-15

Locations

1 site across 1 country: United States