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

Phase 4

Withdrawn

• Conditions: leukemia and myelodysplasia; 10024324

• Registration Number: NL-OMON46533
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

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• Status: Withdrawn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>