Pre B ALL Clinical Trial
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.
| Status | Not yet recruiting |
| Enrollment | 60 |
| Est. completion date | May 2019 |
| Est. primary completion date | January 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 1 Year to 18 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital | Turkish Society of Hematology |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 |