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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Lymphoblastic Leukemia ALL
• Intervention / Treatment: Drug: Asparaginase-induced in vitro T-cell stimulation

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: PIERRE-SIMON ROHRLICH, Professor; Phone Number: 0492034702; Email: rohrlich.ps@chu-nice.fr

Study Locations

• France
  • Marseille, France, 13354
    • APHM
    • Contact: Paul SAULTIER, Professeur; Email: Paul.SAULTIER@ap-hm.fr
  • CHU de Nice
    • Nice, CHU de Nice, France, 06003
      • Chu de Nice
      • Contact: PIERRE-SIMON ROHRLICH; Phone Number: 0492034702; Email: rohrlich.ps@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: In vitro exposure to asparaginase; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At inclusion (baseline) day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: PIERRE-SIMON ROHRLICH, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Asparaginase
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, Lymphoid; Leukemia; Hemic and Lymphatic Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Other Study ID Numbers: 25-AOIP-03; IDRCB (Other Identifier: 2025-A01568-41)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No