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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

Full criteria on ClinicalTrials.gov

Sites (1)

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SiteCityCountrySite status
Aarhus University Hospital
Coordinator of this site? Confirm its status
Aarhus NDenmarkUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.