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

NCT07529223 | Not Yet Recruiting

• 2 other identifiers: 25-AOIP-03IDRCB
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Asparaginase

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

In vitro exposure to asparaginase

EXPERIMENTAL

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

Interventions

Asparaginase-induced in vitro T-cell stimulation DRUG

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.

In vitro exposure to asparaginase

Eligibility Criteria

• Age: 1 Year - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (2)

CHU de Nice

Nice, CHU de Nice, 06003, France

Location

APHM

Marseille, 13354, France

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• PIERRE-SIMON ROHRLICH

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PIERRE-SIMON ROHRLICH, Professor

CONTACT

0492034702; rohrlich.ps@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 14, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)