PK/PD of corticosteroids in graft-versus-host disease after hematopoietic cell transplantation in children

PK/PD of corticosteroids in graft-versus-host disease after hematopoietic cell transplantation in children - PIKACHU-study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54530

Enrollment

130

Registered

2019-09-17

Start date

2020-09-30

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft-versus-host disease Reversed rejection

Interventions

None listed

Eligibility

Age

No minimum to 64 Years

Inclusion criteria

Inclusion criteria: Patients treated by the PMC or LUMC;Planned to receive systemic corticosteroids after HCT; Informed consent form (ICF) signed prior to participation in the study;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 prednisolone as measured by area-under-the-curve (AUC), maximum concentration (Cmax) or 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.	—

Measure

Time frame

Exposure to prednisolone as measured by area-under-the-curve (AUC), maximum concentration (Cmax) or 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.

—

Countries

Netherlands

Contacts

Public ContactC.A. Lindemans

Prinses Máxima Centrum voor Kinderoncologie

C.A.Lindemans-2@prinsesmaximacentrum.nl088 972 72 72

Outcome results