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Forecasting Hypersensitivity Against PEG-asparaginase to Optimize Outcome in ALL

NCT06195735 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 649

Last updated 2024-01-08

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Uppsala University

    collaborator OTHER

  • University of Aarhus

    collaborator OTHER

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Birgitte K Albertsen, M.D. · Aarhus University Hospital, Denmark

Eligibility

Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-17
Primary Completion
2023-12-21
Completion
2023-12-21

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06195735 on ClinicalTrials.gov