NCT06195735Completed
Forecasting Hypersensitivity Against PEG-asparaginase to Optimize Outcome in ALL
Source: ClinicalTrials.gov · Last updated 8 Jan 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 649 (actual)
- First submitted
- 14 Dec 2023
- Start date
- 17 Jul 2020
- Primary completion date
- 21 Dec 2023
- Lead sponsor
- Aarhus University Hospital
- NCT number
- NCT06195735
What you commit to
- Study type: Observational
- Participants enrolled: 649
- From 17 Jul 2020 to the primary completion date, 21 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- None
Who the study is looking for
- Treated for acute lymphoblastic leukemia (ALL) on the ALLTOGETHER main protocol
Age in the registry: - to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.