Evaluation of the intracellular pharmacokinetics of decitabine in patients with leukemia or myelodysplasia
Phase 4
Withdrawn
- Conditions
- leukemia and myelodysplasia10024324
- Registration Number
- NL-OMON46533
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
Diagnosed AML or MDS according to WHO-guidelines, >18 years, planned for treatment start with decitabine (ten-day cycle)
Exclusion Criteria
<18 years
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Intracellular concentrations of decitabine<br /><br>• Intracellular concentrations of decitabine phosphates<br /><br>• Amount of genomic DNA incorporated decitabine related to the amount of<br /><br>incorporated 2*-deoxycytidine (endogenous compound)<br /><br>• Assessment of the methylation grade of genomic DNA by quantitation of<br /><br>methylated 2*-deoxycytidine (5-methyl-2*-deoxycytidine)</p><br>
- Secondary Outcome Measures
Name Time Method <p>not applicable</p><br>
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
How does decitabine's intracellular pharmacokinetics correlate with DNA methylation patterns in leukemia/myelodysplasia patients?
What is the comparative efficacy of decitabine versus azacitidine in myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) post-marketing?
Which DNMT1 or IDH mutation biomarkers predict decitabine response in patients with myelodysplasia or leukemia?
What adverse events are associated with decitabine intracellular accumulation in phase IV leukemia/MDS trials and how are they managed?
How do decitabine combination strategies with HDAC inhibitors or IDH1/2 inhibitors impact intracellular drug dynamics in hematologic malignancies?