Asparaginase treatment in infants with acute lymphoblastic leukemia; pharmacokinetics and asparaginase hypersensitivity in Interfant-06
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Published on: October 17, 2025
Birgitte Klug Albertsen1, Arja Harila-Saari2, Kirsi Jahnukainen3
1a Children and Adolescent Health , Aarhus University Hospital , Aarhus , Denmark.
Insights
Therapeutic drug monitoring of asparaginase is crucial for infant acute lymphoblastic leukemia (ALL). Patients with hypersensitivity reactions often have ineffective treatment due to drug inactivation.
Area of Science:
- Pediatric Oncology
- Pharmacology
- Hematology
Background:
- Infant acute lymphoblastic leukemia (ALL) is rare, with asparaginase being a critical treatment component.
- Evaluating asparaginase efficacy and safety in infants is essential for optimizing outcomes.
- The Interfant-06 trial investigated asparaginase preparations in this vulnerable population.
Purpose of the Study:
- To assess the pharmacokinetics of native *E. coli* asparaginase and PEG-asparaginase in infants with ALL.
- To evaluate the incidence and impact of hypersensitivity reactions on treatment efficacy.
- To determine the necessity of therapeutic drug monitoring for infant ALL treatment optimization.
Main Methods:
- Intramuscular administration of native *E. coli* asparaginase (Asparaginase Medac®) and PEG-asparaginase (Oncaspar®).
- Pharmacokinetic analysis of enzyme activity in patients.
- Monitoring of hypersensitivity reactions and clinical symptoms during treatment.
Main Results:
- Patients without hypersensitivity maintained adequate enzyme activity with both asparaginase preparations.
- Hypersensitivity reactions correlated with undetectable enzyme activity, indicating ineffective therapy.
- Inactivation of asparaginase was observed in patients experiencing hypersensitivity.
Conclusions:
- Therapeutic drug monitoring is vital for identifying asparaginase inactivation in infant ALL.
- Switching to alternative asparaginase preparations is recommended for patients with drug inactivation.
- Optimizing asparaginase therapy through monitoring can improve outcomes for infants with ALL.
Abstract:
Acute lymphoblastic leukemia (ALL) is a rare disease in infants. Asparaginase is an essential part of the treatment, and there Acute is a need to evaluate the efficiency and safety of this drug in this age group. We evaluated the pharmacokinetics of intramuscularly administered native E. coli asparaginase (Asparaginase Medac®) and PEG-asparaginase (Oncaspar®) as well as hypersensitivity reactions during treatment in Interfant-06 ( www.clinicaltrials.gov : NCT01025804). All patients without hypersensitivity had sufficiently high enzyme activity levels during treatment with both preparations. Patients with hypersensitivity reactions during treatment, characterized by the presence of either or not of clinical symptoms and no measurable enzyme activity, received ineffective therapy. For optimization of the bad prognosis in infant ALL, therapeutic drug monitoring should be performed for identification of patients who should be switched to a different asparaginase preparation because of inactivation of the drug.
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