Clinical trial · Observational
Pharmacokinetics and Immunogenicity of the First Doses of PEG-Asparaginase -An ALLTogether Pilot Study
- 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)
Acute lymphoblastic leukemia (ALL) is the most common malignant disease in childhood. Survival rates exceed 90% in children and 75% in adults (aged 18-45 years). During the induction period Asparaginase is an indispensable part of the multiagent treatment, but is often associated with hypersensitivity, either with clinical allergy or silent inactivation. In both cases, Asparaginase is inactivated. It is well known that truncation of Asparaginase treatment due to inactivation reduces survival. To approach understanding Asparaginase dynamics and hypersensitivity in ALL patients it is important to examine the pharmacokinetics of Asparaginase. The aim of this study is to identify serological parameters for prediction of hypersensitivity reaction after the first doses of PEG-Asparaginase given intravenously on the ALLTogether protocol.
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 |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of participants with hypersensitivity Clinical allergy / silent inactivation
- timeFrame
- 2018-2021
- description
- Patients with allergic reactions or silent inactivation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Treated for acute lymphoblastic leukemia (ALL) on the ALL2GETHER pilot protocol Exclusion Criteria: * none
References
Publications (0)
Data not yet available