Acute Lymphoblastic Leukemia, B-CellNCT07509385
The Role of Serum Cytokines IL_17 A and IL_10 in Disease Activity of Acute B Lymphoblastic Leukemia in South Egypt
An observational study of Acute Lymphoblastic Leukemia, B-Cell, run by Assiut University.
Trial summary
Study aimsTo measure the serum levels of IL-17 A and IL-10 in newly diagnosed patients with B-cell acute lymphoblastic leukemia (B-ALL). 2-To study the association between serum cytokine levels (IL-17 A and IL-10) and laboratory parameters, as well as the response to treatment Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Acute Lymphoblastic Leukemia, B-Cell
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2026to 29 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: newly diagnosed B-cell Acute Lymphoblastic Leukemia patients and age and sex matched healthy controls recruited from Assiut University Hospital
Who may be able to join
- Newly diagnosed acute B lymphoblastic leukemia patient
Who cannot join
- patients who received chemotherapy or immunotherapy
- patients with other malignancies
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Study aimsTo measure the serum levels of IL-17 A and IL-10 in newly diagnosed patients with B-cell acute lymphoblastic leukemia (B-ALL).
2-To study the association between serum cytokine levels (IL-17 A and IL-10) and laboratory parameters, as well as the response to treatment
Read the detailed description
Acute Lymphoblastic Leukemia (ALL) is a clonal malignant disorder of lymphoid progenitor cells, characterized by uncontrolled proliferation and accumulation of immature lymphoblasts in the bone marrow, peripheral blood, and extramedullary tissues. It is the most common childhood malignancy worldwide. Although survival rates have improved with risk-adapted chemotherapy and immunotherapy, relapse and treatment resistance remain major challenges, particularly among high-risk pediatric patients [1,2].
ALL is genetically and cytogenetically heterogeneous, but the bone marrow immune microenvironment also plays a critical role in disease progression. Cytokine-mediated interactions between leukemic blasts and immune cells create a permissive niche that supports proliferation, survival, and immune evasion. The balance between T helper 17 (Th17) cells and regulatory T cells (Tregs) is particularly important, as its disruption may promote chronic inflammation and impair anti-leukemic immune responses [3,4].
Interleukin-17A (IL-17A), the signature cytokine of Th17 cells, is a potent pro-inflammatory mediator that induces IL-6 and TNF-α production and activates STAT3 and NF-κB signaling pathways. IL-17A can enhance tumor-associated immune responses, promote angiogenesis, recruit immunosuppressive cells, and support malignant cell survival.[5] Conversely, Interleukin-10 (IL-10), produced mainly by Tregs, B cells, and some myeloid cells, is an anti-inflammatory cytokine that maintains immune homeostasis by limiting T cell activation and antigen presentation. Elevated IL-10 levels in ALL are associated with an immunosuppressive bone marrow environment, higher blast burden, and poor treatment response, suggesting its potential as a prognostic biomarker [6,7].
Overall, the interplay between pro-inflammatory cytokines such as IL-17A and anti-inflammatory cytokines such as IL-10 shapes the bone marrow microenvironment in ALL. Evaluating serum IL-17A and IL-10 levels may provide valuable prognostic information and enhance understanding of the disease's immunopathogenesis [1-4].
- Conditions
- Acute Lymphoblastic Leukemia, B-Cell
- Keywords
- interleukins
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
detection serum cytokine IL-17A and IL-10 level in Acute B-Lymphoblastic Leukemia
Measured: at baseline
Secondary outcomes (1)
Study association between IL-17 A and IL-10 and clinicolaboratory data and patient outcome in Acute B Lymphoblastic leukemia patients
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start31 Mar 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion29 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic Leukemia, B-CellStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Gamal Abd El-Nasser, Assiut University
- Investigators
- Hosni badrawi Hamed, professor, Principal investigator, Assiut UniversityMohamed galal elnagar, associated professor, Principal investigator, Assiut Universitysafia abd elhkem hussien, lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509385
- Sponsor's protocol ID
- Interleukins in B-ALL
- Status last verified
- Mar 2026
- First submitted
- 29 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhao S, Wu D, Wu P, Wang Z, Huang J. Serum IL-10 Predicts Worse Outcome in Cancer Patients: A Meta-Analysis. PLoS One. 2015 Oct 6;10(10):e0139598. doi: 10.1371/journal.pone.0139598. eCollection 2015.
PubMed 26440936Lee KY, Maggi M, Scotti C. Editorial: Biomarkers and therapeutic strategies in acute lymphoblastic leukemia. Front Cell Dev Biol. 2023 May 17;11:1211569. doi: 10.3389/fcell.2023.1211569. eCollection 2023. No abstract available.
PubMed 37266454Iacobucci I, Mullighan CG. Genetic Basis of Acute Lymphoblastic Leukemia. J Clin Oncol. 2017 Mar 20;35(9):975-983. doi: 10.1200/JCO.2016.70.7836. Epub 2017 Feb 13.
PubMed 28297628Ouyang W, O'Garra A. IL-10 Family Cytokines IL-10 and IL-22: from Basic Science to Clinical Translation. Immunity. 2019 Apr 16;50(4):871-891. doi: 10.1016/j.immuni.2019.03.020.
PubMed 30995504Ishida H. [Clinical implication of IL-10 in patients with immune and inflammatory diseases]. Rinsho Byori. 1994 Aug;42(8):843-52. Japanese.
PubMed 7933621
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Serum Cytokines IL_17 A and IL_10 in Disease Activity of Acute B Lymphoblastic Leukemia in South Egypt
- ClinicalTrials.gov ID
- NCT07509385
- Acronym / sponsor ID
- Interleukins in B-ALL
- Conditions
- Acute Lymphoblastic Leukemia, B-Cell
- Keywords
- interleukins
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 29 May 2027 (estimated)
- First posted
- 3 Apr 2026 (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.
Study aimsTo measure the serum levels of IL-17 A and IL-10 in newly diagnosed patients with B-cell acute lymphoblastic leukemia (B-ALL).
2-To study the association between serum cytokine levels (IL-17 A and IL-10) and laboratory parameters, as well as the response to treatment
Detailed description
Acute Lymphoblastic Leukemia (ALL) is a clonal malignant disorder of lymphoid progenitor cells, characterized by uncontrolled proliferation and accumulation of immature lymphoblasts in the bone marrow, peripheral blood, and extramedullary tissues. It is the most common childhood malignancy worldwide. Although survival rates have improved with risk-adapted chemotherapy and immunotherapy, relapse and treatment resistance remain major challenges, particularly among high-risk pediatric patients [1,2].
ALL is genetically and cytogenetically heterogeneous, but the bone marrow immune microenvironment also plays a critical role in disease progression. Cytokine-mediated interactions between leukemic blasts and immune cells create a permissive niche that supports proliferation, survival, and immune evasion. The balance between T helper 17 (Th17) cells and regulatory T cells (Tregs) is particularly important, as its disruption may promote chronic inflammation and impair anti-leukemic immune responses [3,4].
Interleukin-17A (IL-17A), the signature cytokine of Th17 cells, is a potent pro-inflammatory mediator that induces IL-6 and TNF-α production and activates STAT3 and NF-κB signaling pathways. IL-17A can enhance tumor-associated immune responses, promote angiogenesis, recruit immunosuppressive cells, and support malignant cell survival.[5] Conversely, Interleukin-10 (IL-10), produced mainly by Tregs, B cells, and some myeloid cells, is an anti-inflammatory cytokine that maintains immune homeostasis by limiting T cell activation and antigen presentation. Elevated IL-10 levels in ALL are associated with an immunosuppressive bone marrow environment, higher blast burden, and poor treatment response, suggesting its potential as a prognostic biomarker [6,7].
Overall, the interplay between pro-inflammatory cytokines such as IL-17A and anti-inflammatory cytokines such as IL-10 shapes the bone marrow microenvironment in ALL. Evaluating serum IL-17A and IL-10 levels may provide valuable prognostic information and enhance understanding of the disease's immunopathogenesis [1-4].
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- newly diagnosed B-cell Acute Lymphoblastic Leukemia patients and age and sex matched healthy controls recruited from Assiut University Hospital
Key inclusion criteria (1 listed)
- Newly diagnosed acute B lymphoblastic leukemia patient
Key exclusion criteria (2 listed)
- patients who received chemotherapy or immunotherapy
- patients with other malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
detection serum cytokine IL-17A and IL-10 level in Acute B-Lymphoblastic Leukemia
Time frame: at baseline
1 secondary outcome
Study association between IL-17 A and IL-10 and clinicolaboratory data and patient outcome in Acute B Lymphoblastic leukemia patients
Time frame: at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Background: PubMed 26440936Zhao S, Wu D, Wu P, Wang Z, Huang J. Serum IL-10 Predicts Worse Outcome in Cancer Patients: A Meta-Analysis. PLoS One. 2015 Oct 6;10(10):e0139598. doi: 10.1371/journal.pone.0139598. eCollection 2015.
- Background: PubMed 37266454Lee KY, Maggi M, Scotti C. Editorial: Biomarkers and therapeutic strategies in acute lymphoblastic leukemia. Front Cell Dev Biol. 2023 May 17;11:1211569. doi: 10.3389/fcell.2023.1211569. eCollection 2023. No abstract available.
- Background: PubMed 28297628Iacobucci I, Mullighan CG. Genetic Basis of Acute Lymphoblastic Leukemia. J Clin Oncol. 2017 Mar 20;35(9):975-983. doi: 10.1200/JCO.2016.70.7836. Epub 2017 Feb 13.
- Background: PubMed 30995504Ouyang W, O'Garra A. IL-10 Family Cytokines IL-10 and IL-22: from Basic Science to Clinical Translation. Immunity. 2019 Apr 16;50(4):871-891. doi: 10.1016/j.immuni.2019.03.020.
- Background: PubMed 7933621Ishida H. [Clinical implication of IL-10 in patients with immune and inflammatory diseases]. Rinsho Byori. 1994 Aug;42(8):843-52. Japanese.
- Individual participant dataSharing planned: No
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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.
Hosni badrawi Hamed, professor principal investigator
Assiut University
Mohamed galal elnagar, associated professor principal investigator
Assiut University
safia abd elhkem hussien, lecturer principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia, B-Cell, run by Assiut University.
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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 3 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dalia Gamal Abd EL_nasser, residant doctor (+201016321671, Dalia.16266095@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection serum cytokine IL-17A and IL-10 level in Acute B-Lymphoblastic Leukemia (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07509385, which also lists 5 linked publications.
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 3 Apr 2026.