Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT00986804
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.
Study:
NCT00986804
Study Brief:
Protocol Section:
NCT00986804