Last reviewed · How we verify
NCT04843514
TDM of Asparaginase in ALL2008
trial in Acute Lymphoblastic Leukemia in 765 participants. Completed in 31 January 2024.
31 January 2024
Quick facts
| Lead sponsor | Aarhus University Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 765 |
| Start date | 1 April 2021 |
| Primary completion | 31 January 2024 |
| Estimated completion | 31 January 2024 |
| Sites | 2 locations across Denmark |
Conditions studied
- Acute Lymphoblastic Leukemia — all drugs for Acute Lymphoblastic Leukemia →
Sponsor
Aarhus University Hospital
Who can join
Adults 1 to 45, any sex, with Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Early prediction of subsequent peg-asparaginase inactivation in acute lymphoblastic leukaemia patients-A NOPHO ALL2008 study.
Dam M, Centanni M, Centanni D, Friberg LE, et al · · 2025 · cited 1× · PMID 40916350 · DOI 10.1111/bjh.70145
Verify or expand the search:
- PubMed search for NCT04843514
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04843514 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Aarhus University Hospital
- Last refreshed: 6 February 2024
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