Pre B ALLNCT03413046
The Effect of Chemotherapy on Regulatory T Cells
An observational study of Pre B ALL and Regulatory T Cell, run by Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre B ALL, Regulatory T Cell
- What is being tested?
- Peripheral and bone marrow sampling
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The patients diagnosed with PreB ALL in a hematology clinic. Healthy children whom are volunraty bone marrow donors.
Who may be able to join
- Children between 1-18 years
- Recent PreB ALL diagnosis
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Pre B ALL, Regulatory T Cell
- Being tested
- Peripheral and bone marrow sampling
- Keywords
- Regulatory T cell, Acute lymphoblastic leukemia, Minimal residual disease
- Medical subject headings
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral and bone marrow samplingDiagnostic test
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 group | Role | What they receive |
|---|---|---|
| ALL | 30 children with a recent diagnosis of PreB ALL Receives: Diagnostic Test: Peripheral and bone marrow sampling | |
| Control | 30 healthy children Receives: Diagnostic Test: Peripheral and bone marrow sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 15 and 33th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study startJan 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre B ALLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Turkish Society of Hematology
- Responsible party
- Principal investigator, Tekin Aksu, Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413046
- Sponsor's protocol ID
- 2017-6
- Status last verified
- Jan 2018
- First submitted
- 21 Dec 2017
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chemotherapy on Regulatory T Cells in Children With Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT03413046
- Acronym / sponsor ID
- 2017-6
- Conditions
- Pre B ALL, Regulatory T Cell
- Keywords
- Regulatory T cell, Acute lymphoblastic leukemia, Minimal residual disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ankara Children's Health and Diseases Hematology and Oncology Training and Research HospitalOther government
- Collaborators
- Turkish Society of Hematology
- Study start
- Jan 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 29 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALL | – | Diagnostic Test: Peripheral and bone marrow sampling30 children with a recent diagnosis of PreB ALL |
| Control | – | Diagnostic Test: Peripheral and bone marrow sampling30 healthy children |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The patients diagnosed with PreB ALL in a hematology clinic. Healthy children whom are volunraty bone marrow donors.
Key inclusion criteria (2 listed)
- Children between 1-18 years
- Recent PreB ALL diagnosis
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral and bone marrow samplingWe obtained blood from peripheral and bone marrow sampling. Then we analyze Treg population and Treg related cytokines with flow cytometry and ELISA methods. | Diagnostic test | ALL, Control |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre B ALL and Regulatory T Cell, run by Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tekin Aksu, MD (00905459100389, tekinaksu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in number of regulatory T-cells at 15 and 33th day during chemotherapy (time frame: Baseline, 15 and 33th day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2018.