The Effect of Chemotherapy on Regulatory T Cells

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Chemotherapy on Regulatory T Cells in Children With Acute Lymphoblastic Leukemia

Conditions
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Regulatory T Cell, Pre B ALL

Intervention / Treatment
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* Diagnostic Test: Peripheral and bone marrow sampling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ALL<br>30 children with a recent diagnosis of PreB ALL | Diagnostic Test: Peripheral and bone marrow sampling<br>* We obtained blood from peripheral and bone marrow sampling. Then we analyze Treg population and Treg related cytokines with flow cytometry and ELISA methods.<br>|
| Control<br>30 healthy children | Diagnostic Test: Peripheral and bone marrow sampling<br>* We obtained blood from peripheral and bone marrow sampling. Then we analyze Treg population and Treg related cytokines with flow cytometry and ELISA methods.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in number of regulatory T-cells at 15 and 33th day during chemotherapy | The number of regulatory T-cells is measured in fresh peripheral and bone marrow blood by flow cytometry. | Baseline, 15 and 33th day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline IL-2, IL-6, IL-10, and TGF-beta levels at 15 and 33th day during chemotherapy | IL-2, IL-6, IL-10, and TGF-beta levels are measured in frozen peripheral and bone marrow blood by ELISA. | Baseline, 15 and 33th day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Regulatory T cell, Acute lymphoblastic leukemia, Minimal residual disease