Outcome Following Truncation of Asparaginase
1 other identifier
observational
1,401
1 country
1
Brief Summary
This study aimed to investigate the outcome of patients who had their asparaginase treatment truncated in the NOPHO ALL2008 protocol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 12, 2019
CompletedFirst Posted
Study publicly available on registry
June 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedMay 20, 2022
May 1, 2022
11.9 years
June 12, 2019
May 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Risk of relapse
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)
5 years
Secondary Outcomes (1)
50% of asparagine doses
5 years
Study Arms (2)
Exposed
Patients who had their asparaginase treatment truncated or had no asparaginase enzyme activity.
Unexposed
Patients who did not have their asparaginase treatment truncated and had measurable asparaginase enzyme activity
Eligibility Criteria
Children aged 1-17.9 years at time of diagnosis.
You may qualify if:
- \- Children treated according to the NOPHO ALL2008 protocol from the 1st of July 2008 - 28th of February 2016.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aarhus University Hospital, Department of Pediatrics Skejby Hospital
Aarhus, Aarhus N, 8200, Denmark
Related Publications (1)
Gottschalk 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: 33150360DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- M.D., PhD, Associate Professor
Study Record Dates
First Submitted
June 12, 2019
First Posted
June 17, 2019
Study Start
July 1, 2008
Primary Completion
June 1, 2020
Study Completion
June 1, 2020
Last Updated
May 20, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share