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Clinical Trials/NCT05428111
NCT05428111
Unknown
Not Applicable

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

Sohag University1 site in 1 country50 target enrollmentAugust 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Lymphoblastic Leukemia in Pediatric
Sponsor
Sohag University
Enrollment
50
Locations
1
Primary Endpoint
Programmed death ligand -1 (PDL-1) by flow cytometry immunophynotyping
Last Updated
3 years ago

Overview

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 .

Registry
clinicaltrials.gov
Start Date
August 2022
End Date
August 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nada Mohamed Rafat

resident doctor at clinical pathology department at sohag oncology center

Sohag University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Programmed death ligand -1 (PDL-1) by flow cytometry immunophynotyping

Time Frame: 6 months

Assess programmed death ligand -1 by flow cytometry immunophynotyping

programmed death-1 (PD-1) by flow cytometry immunophynotyping

Time Frame: 6 months

Assess programmed death-1 by flow cytometry immunophynotyping

Study Sites (1)

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