The primary objective is to perform a clinical validation of dried blood spot microsampling of imatinib, dasatinib, nilotinib, gilteritinib, midostaurin, and venetoclax. The secondary objective is to test the feasibility of home monitoring (…
ID
Source
Brief title
Condition
- Leukaemias
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the method agreement between plasma and microsampling
(DBS/VAMS). The secondary endpoints are the success rate of microsampling and
the difference in SUS score between HemaXis DB 10 and Mitra Clamshell.
Secondary outcome
• Success rate of microsampling: calculated by the percentage of DBS/VAMS
spots that was accepted for analysis by the laboratory technician. Reasons for
disapproval will be described by the laboratory technician .
• SUS score: calculated by converting the questionnaire into a 0 to 100 scale
score. In the SUS scale, *strongly disagree* correlates with 1 point,
*disagree* with 2 points, *neutral* with 3 points, *agree* with 4 points and
*strongly agree* with five points. The SUS score equals to (X + Y) x 2.5. X is
the sum of the points for all odd-numbered questions minus 5. Y is 25 minus the
sum of all even-numbered questions.
Background summary
Orally administered oncolytics are characterised by high interpatient
variability in pharmacokinetics. Individual patients are therefore potentially
at risk to receive either subtherapeutic or supratherapeutic treatment.
Therapeutic drug monitoring (TDM) is a well-established method for personalized
dosing of drugs, and has become part of standard of care in medical and
hemato-oncology when treating patients with a number of frequently used oral
oncolytics, e.g. imatinib, dasatinib, and nilotinib. Currently, blood sampling
is performed at the hospital. Dried blood spot microsampling of oral oncolytics
offers a home based alternative with multiple benefits. It could reduce the
burden of hospital visits for blood sampling. Additionally, it offers the
opportunity to move from dose recommendation based on trough concentrations
(Ctrough) to recommendations based on Area Under the concentration versus time
Curve (AUC). However, clinical validation and implementations studies for
microsampling are warranted.
Study objective
The primary objective is to perform a clinical validation of dried blood spot
microsampling of imatinib, dasatinib, nilotinib, gilteritinib, midostaurin, and
venetoclax. The secondary objective is to test the feasibility of home
monitoring (microsampling TDM) of these drugs in oncology and hemato-oncology
patients.
Study design
A single center prospective clinical validation study.
Intervention
Patients will be asked to provide twelve microsampling samples obtained by
finger prick (eight dried microsampling spots and four wet blood samples in
microtainer EDTA) and four plasma samples obtained by venepuncture. The paired
samples have to be obtained within 5 minutes of each other. Sampling will take
place before the ingestion of the oral oncolytic (trough concentration,
Ctrough) and every hour up to three hours after drug administration (C1, C2 and
C3). Microsampling collection will be performed using two different sampling
devices, HemaXis DB 10 and the Mitra Clamshell. Patients will be assisted by a
nurse practitioner with the sampling of the first spot, and the sampling of the
remaining spots will be performed by the patient. In order to evaluate the
feasibility of at home microsampling with both sampling devices, patients will
receive two kits for home use of both HemaXis DB 10 and Mitra Clamshell.
Patients will be asked to perform four blood trough concentrations at home, two
with every device. After obtaining the fourth sample, patients will be asked to
send the samples by regular mail to the laboratory. In order to evaluate the
user-friendliness of both microsampling devices, patients will be asked to fill
the System Usability Scale (SUS).
Study burden and risks
Patients will be asked to perform the blood sampling while in the hospital for
regular blood sampling. The remainder of sampling shall be performed at home to
decrease the burden. Since the only invasive procedure is venepuncture and
microsampling finger prick, the risk of adverse events is very low. No effect
is expected on treatment outcome as results of the microsampling will not be
available to inform treatment. The risk of participating in this trial is very
low.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• Willing and able to provide informed consent;
• 18 years of age or older;
• Using one of the following drugs:
o Imatinib
o Dasatinib
o Nilotinib
o Gilteritinib
o Midostaurin
o Venetoclax
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Not able to sample themselves using a finger prick.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL86162.058.24 |