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Testing immune cell reactions to asparaginase in leukemia patients

Lab tests of immune cells reacting to asparaginase in patients with acute lymphoblastic leukemia.

Plain-language title generated from the registry record
Registry title: Role of T Lymphocytes in Hypersensitivity Reactions to Asparaginase in Patients Treated for Acute Lymphoblastic Leukemia.

Key facts

Where
Marseille and Nice, FranceSee the 2 sites

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 1 and 99 years old?

Source: NCT07529223, who can take part

Where in France

  • APHMMarseille, FranceNo longer taking part
  • CHU de NiceNice, FranceNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
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  4. What happens if I want to stop?
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Trial details

Who runs it
Centre Hospitalier Universitaire de Nice
Trial code
NCT07529223
Record updated
14 April 2026
Original description
Acute lymphoblastic leukemia is a type of blood cancer that primarily affects children. Fortunately, current treatments are highly effective. One of the key drugs used is asparaginase, which works by depriving leukemic cells of a substance that is essential for their survival.Read full original descriptionShow less

Role of T Lymphocytes in Hypersensitivity Reactions to Asparaginase in Patients Treated for Acute Lymphoblastic Leukemia. ASTRA - Asparaginase T Cell Response Analysis

Acute lymphoblastic leukemia is a type of blood cancer that primarily affects children. Fortunately, current treatments are highly effective. One of the key drugs used is asparaginase, which works by depriving leukemic cells of a substance that is essential for their survival.

However, asparaginase can also cause adverse effects, including severe allergic reactions in some patients. These reactions may be related to specific genetic factors and/or individual differences in immune responses.

The aim of this research project is to better understand why certain patients develop poor tolerance to asparaginase. To achieve this, the investigators plan to collect blood cells from patients during treatment and then re-expose these cells to the drug in the laboratory. the investigators will assess whether specific immune cells-particularly T lymphocytes-become abnormally activated, which could help explain hypersensitivity reactions.

Ultimately, our goal is to develop a biological assay capable of predicting which patients are at increased risk of reacting adversely to asparaginase, so that they can be offered a more tailored and safer treatment strategy.

Inclusion: Confirmed diagnosis of B- or T-lineage acute lymphoblastic leukemia (ALL) according to current morphological, immunophenotypic, and molecular criteria; Treatment according to a standard therapeutic protocol including administration of asparaginase (PEG-asparaginase or native E. coli asparaginase); Age ≥ 1 year; Inclusion prior to the consolidation phase (sampling scheduled between induction and consolidation).

Exclusion: Prior hematopoietic stem cell transplantation (HSCT); Trisomy 21 (Down syndrome), due to distinct immunological features and potentially different tolerance to asparaginase; Emergency situation or clinical context not allowing appropriate patient information and informed consent.

ClinicalTrials.gov NCT07529223