Pharmacokinetics of treosulfan in children undergoing hematopoietic stem cell transplantation

Pharmacokinetics of treosulfan in children undergoing hematopoietic stem cell transplantation - Pharmcokinetics of treosulfan in children

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41480

Enrollment

Registered

2013-04-02

Start date

2013-04-03

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

Patients undergoing an allogeneic stem cell transplantation due to a malignant or non-malignant immuno-hematologic disease. Chemotherapeutic drug prior to stem cell transplantation

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Pediatric patients undergoing stem cell transplantation Receiving treosulfan as part of their conditioning regimen Permanent venous access

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
The main study parameters are the population pharmacokinetic parameters of treosulfan, defined as treosulfan clearance, treosulfan half-life, area under the concentration time curve over 24 hours and inter- and intrapatient variability in PK parameters in the patient population.	—

Secondary

Measure	Time frame
In the second part of the study the PK parameters of treosulfan will be correlated with clinical outcome of the patient in. The following parameters will be taken into account. • Stem cell engraftment • 100-day treatment related toxicity. • Survival • Relapse • Occurrence of GVHD acute and chronic.	—

Countries

Netherlands

Outcome results