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NCT06195735
Forecasting Hypersensitivity Against PEG-asparaginase to Optimize Outcome in ALL
trial in Acute Lymphoblastic Leukemia in 649 participants. Completed in 21 December 2023.
21 December 2023
Quick facts
| Lead sponsor | Aarhus University Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 649 |
| Start date | 17 July 2020 |
| Primary completion | 21 December 2023 |
| Estimated completion | 21 December 2023 |
| Sites | 1 location across Denmark |
Conditions studied
- Acute Lymphoblastic Leukemia — all drugs for Acute Lymphoblastic Leukemia →
Sponsor
Aarhus University Hospital
Who can join
Under 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 acute lymphoblastic leukemia (ALL). Clinical hypersensitivity reactions and PEG-asparaginase inactivation is common (12-13% of the patients on the NOPHO (Nordic Society for Paediatric Haematology and Oncology) ALL2008 protocol) and has become even more frequent after changing to the current Western European ALL Treatment protocol ALLTogether, despite the PEG coat, leading to increased asparaginase clearance and treatment truncation. Suboptimal anticancer therapy occurs in an additional 3-4% of the patients, who encounter expedited asparaginase clearance but no allergy symptoms (silent inactivation). The aim of this study is to validate and potentially refine an already existing PEG-asparaginase pharmacokinetic model on data from patients treated according to the A2G main protocol.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06195735
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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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 NCT06195735 (US National Library of Medicine, public domain)
- 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: 8 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06195735.
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