The Effect of Chemotherapy on Regulatory T Cells

• Conditions: Pre B ALL; Regulatory T Cell
• Interventions: Diagnostic Test: Peripheral and bone marrow sampling

• Registration Number: NCT03413046
• Lead Sponsor: Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-21
• Status Verified: 2018-01
• Study Start: 2018-01
• Study First Submitted QC: 2018-01-21
• Last Update Submitted: 2018-01-21
• Study First Posted: 2018-01-29
• Last Update Posted: 2018-01-29
• Primary Completion: 2019-01
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ALL	Peripheral and bone marrow sampling	30 children with a recent diagnosis of PreB ALL
Control	Peripheral and bone marrow sampling	30 healthy children

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.