Clinical trial · Interventional
Poly(Ethylene Glycol)(PEG)-Asparaginase During Two Treatment Courses
PEG-asparaginase During Two Treatment Courses in the Treatment of Childhood Acute Lymphoblastic Leukemia
NCT00192673CI-TRIAL-00002677unknownPhase 4ClinicalTrials.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 1. to determine the correct dose for intramuscular administration 2. to compare the frequency of antibody formation after intramuscular administration of native E.coli asparaginase and PEG-asparaginase during two treatment courses in the treatment of childhood lymphoblastic leukemia
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 |
|---|---|---|---|
| PEG-asparaginase | Drug | Pegaspargase | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Determination of the dose that secures sufficient treatment during 14 days
- measure
- Determination of the frequency of antibody formation during treatment with PEG-asparaginase during two treatment courses
Secondary outcomes (1)
- measure
- Comparison of 5-year EFS between groups
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 14 Years
Show eligibility criteria text
Inclusion Criteria: * 1-17 years * Newly diagnosed ALL (high intensive) * Treated according to the NOPHO-2000 protocol * Treated at one of the Nordic pediatric oncology centers Exclusion Criteria: * \<1 year and \>18 years * Newly diagnosed ALL other than high intensive * Not treated according to the NOPHO-2000 protocol * Not treated at one of the Nordic pediatric oncology centers * Allergy to the contents * Pancreatitis (Active or earlier)
References
Publications (1)
- DERIVEDAlbenberg L, Brensinger CM, Wu Q, Gilroy E, Kappelman MD, Sandler RS, Lewis JD. A Diet Low in Red and Processed Meat Does Not Reduce Rate of Crohn's Disease Flares. Gastroenterology. 2019 Jul;157(1):128-136.e5. doi: 10.1053/j.gastro.2019.03.015. Epub 2019 Mar 11. PMID 30872105