TDM of Asparaginase in ALL2008
Therapeutic Drug Monitoring of Asparaginase in Patients Treated on the NOPHO ALL2008 Protocol
1 other identifier
observational
765
1 country
2
Brief Summary
Asparaginase is a cornerstone in the treatment of ALL. In most contemporary protocols like in NOPHO ALL2008 prolonged asparaginase treatment has been implemented. Publish data from NOPHO ALL2008 show sufficient treatment of the majority of patients (analysing trough levels of asparaginase after 2 weeks) but 13% of the patients experience an allergic reaction to this foreign protein (85% of them after the 2nd or 3rd dose) and they have no enzyme activity even before the reaction, meaning that they don't benefit from the treatment at all. In addition 4-5% of the patients have no enzyme activity through the whole treatment without hypersensitivity symptoms. So in reality approximately 20% of the patients don't receive any asparaginase treatment. Therapeutic Drug Monitoring (TDM) of asparaginase has been established in Aarhus, Denmark, under the leadership of Birgitte Klug Albertsen (BKA). From February 2017 the centers have been invited to send samples (extended sampling) in order to gain more knowledge about the pharmacokinetics, to identify patients without activity and to establish the logistics for TDM of asparaginase, which will be mandatory in the next protocol ALLTogether, presumably opening in 2018. From February 2016 an extended sampling for enzyme activity measurements was started and will continue until NOPHO ALL2008 closes. These samples will make it possible to do more in depth pharmacokinetic studies as well as identify the optimal sampling time points for identifying no-activity patients in the future. A database is being developed for TDM in ALLTogether, but it will also include all the asparaginase measurements in ALL2008.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for all trials
Started Apr 2021
Typical duration for all trials
2 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2021
CompletedFirst Submitted
Initial submission to the registry
April 9, 2021
CompletedFirst Posted
Study publicly available on registry
April 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2024
CompletedFebruary 6, 2024
February 1, 2024
2.8 years
April 9, 2021
February 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Description of the pharmacokinetics after administration of PEG-asparaginase 1000 IU/m2 in NOPHO ALL2008, cohort February 2017 and on
2018-2021
Eligibility Criteria
Alle patients in the NOPHO countries aged 1-45 years treated for ALL on the NOPHO ALL2008 protocol and have asparaginase-activity-samples sent to Aarhus.
You may qualify if:
- ALL treated on the NOPHO ALL2008 protocol, age 1-45 years.
You may not qualify if:
- No samples sent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Aarhus University Hospital, Denmark
Aarhus N, 8200, Denmark
Aarhus University Hospital
Aarhus N, 8200, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., PhD, Associate Professor
Study Record Dates
First Submitted
April 9, 2021
First Posted
April 13, 2021
Study Start
April 1, 2021
Primary Completion
January 31, 2024
Study Completion
January 31, 2024
Last Updated
February 6, 2024
Record last verified: 2024-02