This clinical trial studies potential genetic markers which might be used to predict which patients with acute myeloid leukemia or myelodysplastic syndromes respond to decitabine. This study will contribute to the efforts to find effective and less toxic therapies to provide durable remissions in a significant proportion of elderly AML patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
114
Washington University School of Medicine
St Louis, Missouri, United States
Correlation of Patient Specific Mutations With Overall Response Rate
-Best response after 4 treatment cycles as assessed according to International Working Group (IWG) criteria; bone marrow for gene sequencing will be collected at baseline; mutations will be correlated with overall response rate --Complete remission (CR), Complete remission with incomplete hematologic recovery (CRi), Marrow complete remission (mCR), Partial remission (PR), Stable disease (SD), Progressive disease (PD)
Time frame: 4 months (4 treatment cycles)
Compare Outcomes of a 10-day Decitabine Per Cycle Regimen to a 5-day Regimen (Historical Controls)
The overall response rate (CR/CRi/mCR/PR) and complete response rate (CR/CRi/mCR) will be compared with historical controls. Response assessed according to IWG criteria.
Time frame: 4 months (4 treatment cycles)
Rate of Mutation Clearance During Treatment
Samples collected at baseline and after 10, 28 and 56 days of therapy; the rate of mutation clearance was measured as mean VAF change per day of treatment and was estimated using linear mixed model for repeated measurement data .
Time frame: Up to Day 56
Peripheral Blood Decitabine Plasma Levels
* To determine whether steady state serum concentrations of decitabine correlated with responses * Complete remission (CR), Complete remission with incomplete hematologic recovery (CRi), Partial remission (PR), Stable disease (SD), Progressive disease (PD), Not applicable (NA) - assessed according to International Working Group (IWG) criteria
Time frame: Day 4
Change in Bone Marrow Methylcytosine
-Change of total bone marrow deoxyribonucleic acid (DNA) methylcytosine from baseline to Day 10
Time frame: Baseline and Day 10
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.