Clinical trial · Observational
The Effect of Chemotherapy on Regulatory T Cells
The Effect of Chemotherapy on Regulatory T Cells in Children With Acute Lymphoblastic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators aimed to study the effect of chemotherapy on regulatory T cells (Tregs) in children with precursor B (PreB) acute lymphoblastic leukemia (ALL) at 15 and 33 days of malignity directed therapy. The investigators will analyze peripheral and bone marrow blood samples of the participants, obtained at diagnosis, 15 and 33 days of treatment, about Treg / non Treg cells and interleukin (IL)-2, IL-6, IL-10, and transforming growth factor (TGF) beta levels. By this means, investigators will search response to chemotherapy. Also, investigators will analyze correlation between Treg population-Treg related cytokines with demographic, clinical and laboratory findings of the participants with ALL at these certain time points. Additionally, the investigators will compare Treg population and minimal residual disease at 15-33 days of malignity directed therapy. Also investigators will compare these Treg-Treg related cytokines obtained from the participants with ALL and a healthy children control group whom are voluntary donors for bone marrow transplantation.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pre B ALL | B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Regulatory T Cell | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Peripheral and bone marrow sampling | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- ALL
- description
- 30 children with a recent diagnosis of PreB ALL
- interventionNames
- Diagnostic Test: Peripheral and bone marrow sampling
- label
- Control
- description
- 30 healthy children
- interventionNames
- Diagnostic Test: Peripheral and bone marrow sampling
Primary outcomes (1)
- measure
- Change from baseline in number of regulatory T-cells at 15 and 33th day during chemotherapy
- timeFrame
- Baseline, 15 and 33th day
- description
- The number of regulatory T-cells is measured in fresh peripheral and bone marrow blood by flow cytometry.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Children between 1-18 years * Recent PreB ALL diagnosis Exclusion Criteria: * Children under 1 or over 18 years * Underlying disease e.g. immune deficiency, germline mutations or diseases * Tcell ALL or acute myeloid leukemia (AML) patients
References
Publications (0)
Data not yet available