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NCT Number: NCT07509385

The Role of Serum Cytokines IL_17 A and IL_10 in Disease Activity of Acute B Lymphoblastic Leukemia in South Egypt

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

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Key information

About this study

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].

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newly diagnosed acute B lymphoblastic leukemia patient

Exclusion criteria

  • patients who received chemotherapy or immunotherapy
  • patients with other malignancies

Treatment and study plan

Primary outcomes

  1. detection serum cytokine IL-17A and IL-10 level in Acute B-Lymphoblastic Leukemia

    Time frame: 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

    Time frame: at baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Dalia Gamal Abd EL_nasser, residant doctor

CONTACT

[email protected]

+201016321671

Hosni Badrawy Hamed, professor

CONTACT

[email protected]

+201060664976

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 3, 2026
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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