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

Not Applicable

• Conditions: Acute Lymphoblastic Leukemia in Pediatric
• Interventions: Diagnostic Test: flow cytometric immunophynotyping

• Registration Number: NCT05428111
• Lead Sponsor: Sohag University

Brief Summary

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 .

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-15
• Study First Submitted QC: 2022-06-19
• Last Update Submitted: 2022-06-19
• Study First Posted: 2022-06-22
• Last Update Posted: 2022-06-22
• Study Start: 2022-08
• Primary Completion: 2023-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age range from 1 day to 18 years old
• Patients who are newly diagnosed and under treatment of acute lymphoblastic leukemia

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Exclusion Criteria

• Other types of acute leukemia rather than acute lymphoblastic leukemia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	flow cytometric immunophynotyping	healthy control individuals
case	flow cytometric immunophynotyping	Newly diagnosed and under treatment cases of acute lymphoblastic leukemic

Primary Outcome Measures

Name	Time	Method
Programmed death ligand -1 (PDL-1) by flow cytometry immunophynotyping	6 months	Assess programmed death ligand -1 by flow cytometry immunophynotyping
programmed death-1 (PD-1) by flow cytometry immunophynotyping	6 months	Assess programmed death-1 by flow cytometry immunophynotyping

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt