Clinical trial · Observational
The Association Between Asparaginase Enzyme Activity Levels and Toxicities in Childhood Acute Lymphoblastic Leukaemia in NOPHOALL 2008
NCT04187248CI-TRIAL-00069109completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
Evaluation of the association between risk and severity of asparaginase associated toxicities and asparaginase enzyme activity levels in children with Acute Lymphoblastic Leukemia treated in the NOPHO-ALL 2008 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Asparaginase | Drug | Asparaginase | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Number of participants with hypersensitivity
- timeFrame
- July 2008 - February 2016
- description
- Clinical allergy / silent inactivation.
- measure
- Number of participants with asparaginase associated pancreatitis
- timeFrame
- July 2008 - February 2016
- measure
- Number of participants with tromboembolism
- timeFrame
- July 2008 - February 2016
- measure
- Number of participants with osteonecrosis
- timeFrame
- July 2008 - February 2016
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * ALL, standard or intermediate risk * Included in the NOPHO ALL2008 protocol (July 2016 - February 2016) * Children (1-17,9 years at diagnosis) Exclusion Criteria: * ALL: high risk disease, ph-, genetic predisposition, bilinear ALL * \< 2 samples for asparaginase enzyme activity measurements
References
Publications (0)
Data not yet available
No reference posted for this study.