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NCT07529223Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 14 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
20 (estimated)
First submitted
26 Mar 2026
Start date
30 Apr 2026
Primary completion date
30 Apr 2027
Lead sponsor
Centre Hospitalier Universitaire de Nice
NCT number
NCT07529223

What you commit to

  • Study type: Interventional
  • Planned participants: 20
  • From 30 Apr 2026 to the primary completion date, 30 Apr 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior hematopoietic stem cell transplantation (HSCT).

Other illness

  • Trisomy 21 (Down syndrome), due to distinct immunological features and potentially different tolerance to asparaginase.

Other

  • Emergency situation or clinical context not allowing appropriate patient information and informed consent.

Who the study is looking for

  • 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).

Age in the registry: 1 year to 99 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
APHM
Coordinator of this site? Confirm its status
MarseilleFranceUnknown status
CHU de Nice
Coordinator of this site? Confirm its status
NiceFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.