Primary objective: To develop and validate a DBS sampling method of nilotinib for TDM purposes. Secondary objectives: To get insight into normal trough plasma levels and the use of the DBSM.
ID
Source
Brief title
Condition
- Leukaemias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference between specimens across blood sampling methods, and between
duplicate specimens for the same blood sampling method will be determined.
Secondary outcome
NA
Background summary
The antitumor drug nilotinib has a large inter- and intra individual
variability of pharmacokinetics. Also adherence can substantially influence
plasma levels. Therapeutic drug monitoring (TDM) of nilotinib is not regularly
performed but could be useful to assess that sufficient plasma levels are
obtained. Plasma concentrations are usually obtained by venous sampling by
medical personel. Dried blood spot sampling (DBSM) could be a useful
alternative sampling method.
Study objective
Primary objective: To develop and validate a DBS sampling method of nilotinib
for TDM purposes. Secondary objectives: To get insight into normal trough
plasma levels and the use of the DBSM.
Study design
The study is designed cross sectional observational in two centers. Venous and
finger prick blood samples will be collected simultaneously. With DBSM,
capillary blood is obtained from a finger prick with an automatic lancet by the
patients themselves and the drop of blood is applied to sampling paper. DBSM is
compared with routine assays in venous blood.
Study burden and risks
Patients are asked once for a blood sample by means of a finger prick, and one
venous blood sample simultaneously taken with the regular blood collection.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
Patients with CML who are treated with nilotinib.
Exclusion criteria
None
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 | NL40127.029.12 |