The Effect of Chemotherapy on Regulatory T Cells

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

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.

Study Overview

• Status: Unknown
• Conditions: Pre B ALL; Regulatory T Cell
• Intervention / Treatment: Diagnostic test: Peripheral and bone marrow sampling

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The patients diagnosed with PreB ALL in a hematology clinic. Healthy children whom are volunraty bone marrow donors.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ALL; 30 children with a recent diagnosis of PreB ALL	Diagnostic test: Peripheral 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.
Control; 30 healthy children	Diagnostic test: Peripheral 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital
• Collaborators: Turkish Society of Hematology

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2018
• Primary Completion (ANTICIPATED): January 1, 2019
• Study Completion (ANTICIPATED): May 1, 2019

Study Registration Dates

• First Submitted: December 21, 2017
• First Submitted That Met QC Criteria: January 21, 2018
• First Posted (ACTUAL): January 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 29, 2018
• Last Update Submitted That Met QC Criteria: January 21, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Acute lymphoblastic leukemia; Regulatory T cell; Minimal residual disease
• Other Study ID Numbers: 2017-6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No