The present study will be focused on exploring the intracellular pharmacokinetics of decitabine
ID
Source
Brief title
Condition
- Leukaemias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• 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)
Secondary outcome
not applicable
Background summary
A recent publication by Anders et al. describes, for the first time, an
analytical method to quantitate genomic DNA incorporated decitabine in a
preclinical setting. The new method can be used for the measurement of
intracellular decitabine phosphates, as well as genomic DNA incorporated
decitabine. This study would be the first to describe the incorporation of
decitabine in a clinical setting.
Study objective
The present study will be focused on exploring the intracellular
pharmacokinetics of decitabine
Study design
In subjects diagnosed with AML or MDS who are treated with 10-days decitabine,
additional whole blood samples will be collected on day 1, day 5 and day 10 of
the same decitabine treatment cycle. Patients will be approached for the first
2 cycles of decitabine.
Study burden and risks
not applicable
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63972.042.17 |