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Clinical Trial NCT07499336 for Acute Lymphoblastic Leukaemia - Category is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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UNDERSTANDING THE T-CELL AND B-CELL RECEPTOR REPERTOIRE IN CHILDREN AND YOUNG ADULTS WITH ANTI-DRUG ANTIBODIES AGAINST PEG ASPARAGINASE 45 Non-Invasive At-Home Biomarker-Driven Pediatric

Not yet recruiting
Clinical Trial NCT07499336 is an observational study for Acute Lymphoblastic Leukaemia - Category and is currently not yet recruiting. Enrollment is planned to begin on April 7, 2026 and continue until the study accrues 45 participants. Led by Aarhus University Hospital, this study is expected to complete by January 31, 2030. The latest data from ClinicalTrials.gov was last updated on March 30, 2026.
Brief Summary
The aim of this sub study is to identify biomarkers in children and young adults with ALL with hypersensitivity to PEG-asparaginase.

Evidence strongly implicates humoral immunity in asparaginase immunogenicity with neutralizing antibodies18. Asparaginase is a bacterial enzyme not naturally present in the human body, and therefore highly immunogenic. Upon administration, antigen-presenting cells internalize and prese...

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Official Title

UNDERSTANDING THE T-CELL AND B-CELL RECEPTOR REPERTOIRE IN CHILDREN AND YOUNG ADULTS WITH ANTI-DRUG ANTIBODIES AGAINST PEG ASPARAGINASE

Conditions
Acute Lymphoblastic Leukaemia - Category
Other Study IDs
  • Asparaginase Hypersensitivity
NCT ID Number
NCT07499336
Start Date (Actual)
2026-04-07
Last Update Posted
2026-03-30
Completion Date (Estimated)
2030-01-31
Enrollment (Estimated)
45
Study Type
Observational
Status
Not yet recruiting
Keywords
ALL
Arms / Interventions
Participant Group/ArmIntervention/Treatment
N/A
Hypersensitivity reaction to asparaginase
We will perform a longitudinal Danish cohort study in pediatric and young adult ALL patients receiving PEG-asparaginase as part of induction and post-consolidation therapy treated on the A2G-1. We will include 20 patients with hypersensitivity and 20 without. Biological samples will be collected at baseline, during early post-exposure with PEG-asparaginase, at clinical hypersensitivity, and at follow-up timepoints ac...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Identify biomarkers in children and young adults with ALL with hypersensitivity to PEG-asparaginase.
Identify biomarkers in children and young adults with ALL with hypersensitivity to PEG-asparaginase.
5 years
Identify biomarkers in children and young adults with ALL with hypersensitivity to PEG-asparaginase.
4 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult
Eligible Sexes
All
  • ALL treated with Asparaginase, either with or without hypersensitivity reaction

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Aarhus University Hospital logoAarhus University Hospital
Study Responsible Party
Birgitte Klug Albertsen, Principal Investigator, Professor, Aarhus University Hospital
Study Central Contact
Contact: Shiva Karoline Leisner, MD, +45 51184224, [email protected]
Contact: Birgitte Klug Albertsen, Professor, [email protected]
No location data.