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The Effect of Chemotherapy on Regulatory T Cells

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ClinicalTrials.gov Identifier: NCT03413046
Recruitment Status : Not yet recruiting
First Posted : January 29, 2018
Last Update Posted : January 29, 2018
Sponsor:
Collaborator:
Turkish Society of Hematology
Information provided by (Responsible Party):
Tekin Aksu, 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.

Condition or disease Intervention/treatment
Pre B ALL Regulatory T Cell Diagnostic Test: Peripheral and bone marrow sampling

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Effect of Chemotherapy on Regulatory T Cells in Children With Acute Lymphoblastic Leukemia
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : May 2019


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.




Primary Outcome Measures :
  1. Change from baseline in number of regulatory T-cells at 15 and 33th day during chemotherapy [ Time Frame: 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 :
  1. Change from baseline IL-2, IL-6, IL-10, and TGF-beta levels at 15 and 33th day during chemotherapy [ Time Frame: 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.



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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The patients diagnosed with PreB ALL in a hematology clinic. Healthy children whom are volunraty bone marrow donors.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03413046


Contacts
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Contact: Tekin Aksu, MD 00905459100389 tekinaksu@gmail.com
Contact: Namık Y Özbek, Prof 00903125969870 namikyozbek@gmail.com

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

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Responsible Party: Tekin Aksu, Principal Investigator, Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03413046     History of Changes
Other Study ID Numbers: 2017-6
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tekin Aksu, Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital:
Regulatory T cell
Acute lymphoblastic leukemia
Minimal residual disease

Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases