Clinical trial · Observational
PEG-Asparaginase Associated Pancreatitis, Hepatotoxicity and Hyperlipidemia in Children With ALL
NCT01393249CI-TRIAL-00025095AAP2008completedClinicalTrials.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)
The purpose of this study is to create a model enabling us to predict pancreatitis, hyperlipidemia and hepatotoxicity during treatment with PEG-Asparaginase in children with Acute Lymphoblastic Leukemia.
Conditions
Conditions (2)
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 |
| Pancreatitis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- ALL, Asparaginase, pancreatitis
- description
- Patients that have been scanned and have had blood tests
Primary outcomes (1)
- measure
- Risk of pancreatitis
- timeFrame
- During asparaginase therapy
- description
- Risk of pancreatitis in relation to host genomic variants, inflammatory markers and ultrasound changes in the weeks prior to clinical pancreatitia
Secondary outcomes (1)
- measure
- Course of pancreatitis
- timeFrame
- In the months following pancreatitis
- description
- Risk of complications, specifically cysts, pain and diabetes in the months following pancratitis. Risk of 2nd episode of pancreatitis if reexposed to asparaginase
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * IR- or SR- type ALL, and treatment with Peg-Asparaginase Exclusion Criteria: * HR ALL, and changing subgroup from IR or SR to HR
References
Publications (0)
Data not yet available
No reference posted for this study.