ClinicalTrials.gg
Status unknownNCT03413046Updated Jan 29, 2018

The Effect of Chemotherapy on Regulatory T Cells

An observational study in Pre B ALL and Regulatory T Cell, sponsored by Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital. Status unknown. Open to participants aged 1 Year to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-29.

Sponsored by Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital · Observational

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Not yet recruiting — may be out of date.

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Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
1 Year to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pre B ALL
  • Regulatory T Cell

Keywords

  • Regulatory T cell
  • Acute lymphoblastic leukemia
  • Minimal residual disease
03

In context

Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

38 studies on the registry are indexed under Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; 16 are open to participants now.

Browse Precursor B-Cell Lymphoblastic Leukemia-Lymphoma studies →

Lead sponsor

Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children between 1-18 years
  • Recent PreB ALL diagnosis

Exclusion criteria

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • ALL

    30 children with a recent diagnosis of PreB ALL

    Diagnostic Test: Peripheral and bone marrow sampling

  • Control

    30 healthy children

    Diagnostic Test: Peripheral and bone marrow sampling

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 15 and 33th day

Secondary outcomes

  1. 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.

    Time frame: Baseline, 15 and 33th day

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2018; primary completion for Jan 2019, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 21, 2017
First posted
Jan 29, 2018
StartEst.
Jan 2018
Primary completionEst.
Jan 2019
CompletionEst.
May 2019
Last update
Jan 29, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03413046
Lead sponsor
Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital
Collaborators
Turkish Society of Hematology
Responsible party
Tekin Aksu (Principal Investigator, Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital) — Principal investigator
First posted
Jan 29, 2018
Start date
Jan 2018 (estimated)
Primary completion
Jan 2019 (estimated)
Completion
May 2019 (estimated)
Last update
Jan 29, 2018

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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