Optimizing of Ciclosporin monitoring, towards improved ciclosporine therapy in children after stem cell transplantation

Optimizing of Ciclosporin monitoring, towards improved ciclosporine therapy in children after stem cell transplantation - AUC monitoring in CsA therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36960

Enrollment

110

Registered

2012-11-08

Start date

2013-02-04

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

atients undergoing an allogeneic stem cell transplantation due to a malignant or non-malignant immuno-hematologic disease. Graft-versus-host disease immuun reaction of transplant against the patients cells

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Pediatric patients of the stem cell transplantation program of the Willem-Alexander Children*s Hospital, LUMC or Wilhelmina Children*s hospital, UMCU undergoing allogeneic stem cell transplantation. Patients starting with intravenous CsA as GVHD prophylaxis.

Exclusion criteria

Exclusion criteria: Absence of central venous access from which the blood samples can be drawn.

Design outcomes

Primary

Measure	Time frame
Acute GvHD, follow up of 100 days. CsA exposure is defined as Area under the Curve over 12 hours.	—

Secondary

Measure	Time frame
CsA trough level Stem cell engraftment Toxicity (renal, liver, neurological)	—

Countries

Netherlands

Outcome results