Clinical trial · Observational
Outcome Following Truncation of Asparaginase
Outcome Following Truncation of Asparaginase in the NOPHO ALL2008 Protocol
NCT03987542CI-TRIAL-00058619completedClinicalTrials.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)
This study aimed to investigate the outcome of patients who had their asparaginase treatment truncated in the NOPHO ALL2008 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 |
|---|---|---|---|
| Relapse Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Exposed
- description
- Patients who had their asparaginase treatment truncated or had no asparaginase enzyme activity.
- label
- Unexposed
- description
- Patients who did not have their asparaginase treatment truncated and had measurable asparaginase enzyme activity
Primary outcomes (1)
- measure
- Risk of relapse
- timeFrame
- 5 years
- description
- Do patients with truncation of asparaginase treatment or no enzyme activity (truncated) have a different risk of relapse compared to patients who have not been truncated and who have measurable enzyme activity (non-truncated)
Secondary outcomes (1)
- measure
- 50% of asparagine doses
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- Children treated according to the NOPHO ALL2008 protocol from the 1st of July 2008 - 28th of February 2016. Exclusion Criteria: * Bilineage ALL * Pre-treatment with glucocorticosteroids or other antileukemic agents for more than 1 week * ALL predisposition syndromes * Previous cancer * Off protocol administration of additional chemotherapy during induction therapy * Sexually active females not using contraception
References
Publications (1)
- DERIVEDGottschalk Hojfeldt S, Grell K, Abrahamsson J, Lund B, Vettenranta K, Jonsson OG, Frandsen TL, Wolthers BO, Marquart HV, Vaitkeviciene G, Lepik K, Heyman M, Schmiegelow K, Albertsen BK. Relapse risk following truncation of pegylated asparaginase in childhood acute lymphoblastic leukemia. Blood. 2021 Apr 29;137(17):2373-2382. doi: 10.1182/blood.2020006583. PMID 33150360