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Evaluation of the intracellular pharmacokinetics of decitabine in patients with leukemia or myelodysplasia

Evaluation of the intracellular pharmacokinetics of decitabine in patients with leukemia or myelodysplasia - intracellular PK of decitabine in patients with leukemia/myelodysplasia

Status
Unknown
Phases
Phase 4
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON46533
Enrollment
6
Registered
2018-04-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

leukemia and myelodysplasia

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Diagnosed AML or MDS according to WHO-guidelines, >18 years, planned for treatment start with decitabine (ten-day cycle)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
• Intracellular concentrations of decitabine • Intracellular concentrations of decitabine phosphates • Amount of genomic DNA incorporated decitabine related to the amount of incorporated 2*-deoxycytidine (endogenous compound) • Assessment of the methylation grade of genomic DNA by quantitation of methylated 2*-deoxycytidine (5-methyl-2*-deoxycytidine)—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)