Clinical trial · Observational
Pharmacokinetics of Asparaginase and Antibody Formation in Interfant-06
Post-marketing Surveillance Study of the Pharmacokinetics of Asparaginase and Antibody Formation in Interfant-06
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Asparaginase is an important drug in the treatment of childhood leukemia including in infant (\<1 year). The prognosis for infants is bad. Information about drug metabolism in neonates and infants is scarce as well as the reactions of an immature immune system to foreign proteins. The aims of this study is to describe the metabolism (pharmacokinetics) of asparaginase after administration intramuscularly and to evaluate the formation of antibodies against the drug (enzyme) during treatment in order to optimize the asparaginase treatment in infants in the future.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Infants
Primary outcomes (1)
- measure
- pharmacokinetics, antibody formation, side effects
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Hour
- Maximum age
- 1 Year
Show eligibility criteria text
Inclusion Criteria: * infants \<1 year at diagnosis * diagnosed with ALL * treated according to the international Interfant-06 protocol * treated at one of the pediatric oncological centers in the Nordic countries Exclusion Criteria: * children \>1 year at diagnosis
References
Publications (1)
- DERIVEDAlbertsen BK, Harila-Saari A, Jahnukainen K, Lahteenmaki P, Riikonen P, Mottonen M, Lausen B. Asparaginase treatment in infants with acute lymphoblastic leukemia; pharmacokinetics and asparaginase hypersensitivity in Interfant-06. Leuk Lymphoma. 2019 Jun;60(6):1469-1475. doi: 10.1080/10428194.2018.1538507. Epub 2019 Jan 11. PMID 30632847