No registrations found.
ID
Source
Brief title
Health condition
allogeneic stem cell transplantation
cyclosporine
TDM
Adverse drug reactions
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Grade acute kidney injury
- Grade nausea
- Grade in tremor
Secondary outcome
Adverse drug reactions
- Headache
- Hypertension
Clinical chemical parameters:
- Glucose
- Potassium
- Magnesium
- Total cholesterol
- High-density lipoproteins
- Liver function
Other parameters:
- Grade GVHD
- Minimal residual disease on day 28; 56; 84; 112; 140 ; 168
- Engraftment
- Quality of life (QoL) will be assessed by means of the validated questionnaires.
Background summary
In this study the Therapeutic Drug Monitoring of cyclosporine with dried blood spot is investigated in allo SCT recipients. 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 design: Single-blind monocentre intervention study
Study population: Patients planned to undergo an allo SCT for malignant hematological disorders and with a related or unrelated 8/8 HLA matched donor are eligible for randomization.
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.
Intervention
CsA monitoring and dose adjustments will be based on trough levels (arm 1) or abbreviated AUC[0-12] (arm 2)
[default]
The Netherlands
[default]
The Netherlands
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
- Written Informed Consent
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
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4742 |
| NTR-old | NTR4996 |
| CCMO | NL42166.029.13 |
| OMON | NL-OMON39871 |