Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-29 @ 11:20 AM
Study NCT ID:
NCT00986804
Status:
COMPLETED
Last Update Posted:
2016-02-15
First Post:
2009-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decitabine Maintenance for Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS) Post Transplant
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
Maintenance Therapy With Decitabine After Allogeneic Stem Cell Transplantation for Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AML MDS
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.
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: