NCT07529223

Role of T Lymphocytes in Hypersensitivity Reactions to Asparaginase in Patients Treated for Acute Lymphoblastic Leukemia.

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 1 Year – 99 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Acute Lymphoblastic Leukemia ALL

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-04-30
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

2 sites across 1 country: France