An interventional study of Asparaginase-induced in vitro T-cell stimulation in Acute Lymphoblastic Leukemia ALL, sponsored by Centre Hospitalier Universitaire de Nice. Not yet recruiting at 2 sites in France. Open to participants aged 1 Year to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Prevention
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.
2,061 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 490 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 1,653 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.
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Exclusion Criteria:
Flow cytometric analysis of asparaginase-specific T-cell activation, compared with an unstimulated control condition and a non-antigen-dependent (polyclonal) stimulation condition. Comparison of asparaginase-specific T-cell activation between patients who developed a clinical reaction to asparaginase and patients who did not.
Drug: Asparaginase-induced in vitro T-cell stimulation
Flow cytometric analysis of asparaginase-specific T-cell activation, compared with an unstimulated control condition and a non-antigen-dependent (polyclonal) stimulation condition. Comparison of asparaginase-specific T-cell activation between patients who developed a clinical reaction to asparaginase and patients who did not.
Percentage of T lymphocytes producing IFN-γ in response to asparaginase stimulation, compared with background (unstimulated) levels and the maximal response induced by PMA/ionomycin within the same patient.
Absolute number of T lymphocytes producing IFN-? in response to asparaginase stimulation
Time frame: At inclusion (baseline) day 1
Plan to share: No
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Centre Hospitalier Universitaire de Nice