The Effect of Chemotherapy on Regulatory T Cells

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03413046

Enrollment

Registered

2018-01-29

Start date

2018-01-31

Completion date

2019-05-31

Last updated

2018-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre B ALL, Regulatory T Cell

Keywords

Regulatory T cell, Acute lymphoblastic leukemia, Minimal residual disease

Brief summary

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.

Interventions

DIAGNOSTIC_TESTPeripheral and bone marrow sampling

We obtained blood from peripheral and bone marrow sampling. Then we analyze Treg population and Treg related cytokines with flow cytometry and ELISA methods.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 18 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Contacts

Primary ContactTekin Aksu, MD

tekinaksu@gmail.com00905459100389

Backup ContactNamık Y Özbek, Prof

namikyozbek@gmail.com00903125969870

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026