Optimizing Erwinase dosing to reach safe trough levels in children and young adults with ALL
Official title: Establishment of a Phamacokinetik Model for Erwinase Pharmacokinetiks
Run by Aarhus University Hospital · NCT07499349 · Data updated 2026-11-12
This project tries to create a dosing model for Erwinase to help children and young adults with ALL reach safe trough drug levels while reducing the risk of high exposures like hyperammonemia.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Month to 45 Years |
| Sex | All |
| Enrollment | 475 (estimated) |
| Sponsor | Aarhus University Hospital Academic / other |
| Locations | 1 site (Aarhus) |
| Status | Recruiting |
| Started | July 1, 2008 |
| Main results expected | June 30, 2026 |
| Study ends | January 30, 2028 |
| Registry record updated | April 15, 2026 |
| Trial ID | NCT07499349 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children and young adults with acute lymphoblastic leukemia who are receiving Erwinase and have therapeutic drug monitoring data available.
✕Probably not a fit
Patients not treated with Erwinase or without available TDM measurements are unlikely to benefit from this modeling effort.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational NOPHO study collects therapeutic drug monitoring data from children and young adults with ALL treated with Erwinase and applies population pharmacokinetic modeling and pharmacometrics to describe drug exposure. Advanced analytical methods will be used to handle sparse and uneven sampling and to quantify sources of variability linked to dosing, patient characteristics, and biomarkers. The effort aims to define dosing rules that improve the probability of achieving target trough levels while minimizing high activity associated with hyperammonemia. Data will be pooled across participating centers, including Aarhus University Hospital and collaborating sites, to strengthen model reliability and support individualized dosing recommendations.
Why it matters
Potential benefit: If successful, the model could help clinicians personalize Erwinase dosing to maintain effective trough levels while lowering the risk of hyperammonemia.
How similar studies have gone: Population PK and TDM approaches have previously been applied to asparaginase preparations in pediatric ALL with useful guidance on dosing, so this work builds on established methods rather than being wholly novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * ALL treated with Erwinase Exclusion Criteria: * not treated with Erwinase
Where it's running
-
Aarhus University Hospital
Aarhus, Denmark Recruiting
Study contacts
- Principal investigator: Shiva Leisner, MD — Aarhus University Hospital
- Study coordinator: Shiva Karoline Leisner, MD
- Email: shiva.leisner@clin.au.dk
- Phone: 0045 51184224
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.