Expression of Programmed Death-1 (PD-1) & Programmed Death Ligand-1 (PDL-1) in Acute Lymphoblastic Leukemia in Pediatric

Study Overview
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Brief Summary
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Acute lymphoblastic leukemia (ALL) is the most common childhood malignancy in the world. It is a malignant clonal proliferation of lymphoid progenitor cells, but most commonly of the B cell lineage (B ALL). . Acute Lymphoblastic Leukemia (ALL) is a heterogeneous disease that causes malignant hematological disorders at any age. It mainly affects children aged 2 to 5; in fact, 60% of pediatric leukemia cases are ALL, with an incidence of 3-4 cases per 100,000 per year. It is divided into two subtypes B-ALL and T-ALL depending on whether transformation occurs in B- or T-cell precursors, respectively . Leukemic cells apply multiple immune evasion mechanisms resulting in tumor progression. One of the most important immune escape mechanisms is over expression of immune checkpoint receptors and their ligands such as PD-1 and PD-L1 . The PD-1 receptor plays a crucial role in a broad spectrum of immune regulatory mechanisms . It is a negative co-receptor that down regulates T-cell activity . PDL 1, which is known as B7 H1 , is a cell surface protein of B7 family member . PD L1 is expressed on all types of lympho hematopoietic cells at variable levels and is constitutively expressed on T cells, B cells, macrophages, and dendritic cells . Tumors exploit the PD-1/PD-L1 pathway to evade host immune surveillance . PD-1/PD-L1 pathway controls the induction and maintenance of immune tolerance within the tumor microenvironment. The activity of PD-1 and its ligands PD-L1 or PD-L2 are responsible for T cell activation, proliferation, and cytotoxic secretion in cancer to produce anti-tumor immune responses .

Official Title
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Expression of Programmed Death-1 (PD-1) & Programmed Death Ligand-1 (PDL-1) in Acute Lymphoblastic Leukemia in Pediatric

Conditions
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Acute Lymphoblastic Leukemia in Pediatric

Intervention / Treatment
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* Diagnostic Test: flow cytometric immunophynotyping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age range from 1 day to 18 years old Patients who are newly diagnosed and under treatment of acute lymphoblastic leukemia Exclusion Criteria: Other types of acute leukemia rather than acute lymphoblastic leukemia

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>healthy control individuals | Diagnostic Test: flow cytometric immunophynotyping<br>* Expression of programmed death-1 (PD-1) & programmed death ligand-1 (PDL-1) in flow cytometric immunophynotyping<br>|
| Active Comparator: case<br>Newly diagnosed and under treatment cases of acute lymphoblastic leukemic | Diagnostic Test: flow cytometric immunophynotyping<br>* Expression of programmed death-1 (PD-1) & programmed death ligand-1 (PDL-1) in flow cytometric immunophynotyping<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| programmed death-1 (PD-1) by flow cytometry immunophynotyping | Assess programmed death-1 by flow cytometry immunophynotyping | 6 months | 
| Programmed death ligand -1 (PDL-1) by flow cytometry immunophynotyping | Assess programmed death ligand -1 by flow cytometry immunophynotyping | 6 months |