The number and severity of adverse drug reactions (renal function, nausea and tremor) of cyclosporine using AUC targeted Therapeutic Drug Monitoring as compared to C0 targeted TDM.
ID
Source
Brief title
Condition
- Leukaemias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Adverse drug reactions (headache, tremor, renal dysfunction, hypertension).
Quality of life (QoL) will be assessed by means of validated questionnaires.
Secondary outcome
Quality of life (QoL) will be assessed by means of validated questionnaires.
Background summary
The routine therapeutic drug monitoring of CsA using predose **trough**
concentration (C0) is accepted practice. Pharmacokinetic studies in renal
transplant patients found that the 12-hour area under the concentration*time
curve (AUC[0*12h]) is a very sensitive predictor of acute rejection incidence
and graft survival at 1 year post-renal transplant [69] and that it is the best
estimate of overall drug exposure, but it is not practical for routine clinical
management.
Development of the Dry Blood Spot (DBS) sampling have made AUC[0-12h]
monitoring more feasible. Patients can perform the fingerprick at home, no
invasive procedure is necessary and monitoring at any desired sampling time can
be undertaken conveniently
Objective: The number and severity of adverse drug reactions (renal function,
nausea and tremor) of cyclosporine using AUC targeted Therapeutic Drug
Monitoring as compared to C0 targeted TDM.
Study objective
The number and severity of adverse drug reactions (renal function, nausea and
tremor) of cyclosporine using AUC targeted Therapeutic Drug Monitoring as
compared to C0 targeted TDM.
Study design
Single-blind monocentre intervention study
Intervention
CsA monitoring and dose adjustments will be based on trough levels (arm 1) or
abbreviated AUC[0-12] (arm 2).
Study burden and risks
One intravenous sample of blood in the clinic will be changed to 3 fingerprick
samples collected by the patient. The patient will answer an 81 item QoL
questionnaire 3 times. The risks associated with the investigational procedure
is negligible and the burden minimal.
de Boelelaan 1117
Amsterdam 1081 HV
NL
de Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
* Age 18-65 inclusive
* AML, MDS, ALL, MM, CML, CLL, NHL, HL, or a myeloproliferative disease (MPD)
* Planned allogeneic stem cell transplantation
* Related or unrelated donor with a 7/8 or 8/8 HLA match (HLA A, B, C, DRB1) or 9/10 or 10/10 MUD match
* WHO performance status 0-2
Exclusion criteria
* Renal dysfunction (serum creatinine > 150 umol/L or clearance < 50 ml/min)
* Patients with active, uncontrolled infection
* Cord Blood transplantation
* Patients with progressive disease in case of MM, CLL, NHL, HL
* Patients with > 5% marrow blasts in case of AML, ALL, CML
* Patients with EMD in case of AML, ALL, CML
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL42166.029.13 |
| OMON | NL-OMON27177 |