Graft versus host disease after hemotopoetic cell transplantation Pharmacokinetics
Conditions
Interventions
Er is geen sprake van een interventie. Het onderzoek betreft observatie van de standaard behandeling
Sponsors
Prinses Maxima Centrum
Universitair Medisch Centrum Utrecht
Eligibility
Age
No minimum to 64 Years
Inclusion criteria
Inclusion criteria: 1. Patients treated by the PMC; 2. Planned to receive systemic corticosteroids after HCT; 3. Informed consent form (ICF) signed prior to participation in the study; 4. A present central line to sample blood
Exclusion criteria
Exclusion criteria: None in advance. However, according to expert opinion of the PI, any disease/circumstance that may influence the participation of the potential subject in a negative way, will be excluded from participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters of prednisolone as either prophylaxis or therapy of GVHD in children after HCT will be assessed, even as other determinants for development of a population PK model using non-linear mixed effect modelling NON-MEM. | — |
Secondary
| Measure | Time frame |
|---|---|
| Exposure to corticosteroids as measured by area-under-the-curve (AUC), maximum concentration (Cmax), minimum concentration (Cmin) and time-above-threshold will be related to treatment outcome. Treatment outcome is defined as occurrence and grade of GVHD in case of prophylactic therapy and defined as the need for escalation of therapy for treatment of GVHD. Biomarkers will be assessed using cell (mostly flowcytometry) and protein (Luminex and Olink) assays. | — |
Contacts
Public ContactJulia Möhlmann
UMC Utrecht
Outcome results
None listed