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

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05428111
Collaborator
(none)
50
1
2
12
4.2

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: flow cytometric immunophynotyping
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Expression of Programmed Death-1 (PD-1) & Programmed Death Ligand-1 (PDL-1) in Acute Lymphoblastic Leukemia in Pediatric
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: control

healthy control individuals

Diagnostic Test: flow cytometric immunophynotyping
Expression of programmed death-1 (PD-1) & programmed death ligand-1 (PDL-1) in flow cytometric immunophynotyping

Active Comparator: case

Newly diagnosed and under treatment cases of acute lymphoblastic leukemic

Diagnostic Test: flow cytometric immunophynotyping
Expression of programmed death-1 (PD-1) & programmed death ligand-1 (PDL-1) in flow cytometric immunophynotyping

Outcome Measures

Primary Outcome Measures

  1. programmed death-1 (PD-1) by flow cytometry immunophynotyping [6 months]

    Assess programmed death-1 by flow cytometry immunophynotyping

  2. Programmed death ligand -1 (PDL-1) by flow cytometry immunophynotyping [6 months]

    Assess programmed death ligand -1 by flow cytometry immunophynotyping

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Day to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag University Hospital Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nada Mohamed Rafat, resident doctor at clinical pathology department at sohag oncology center, Sohag University
ClinicalTrials.gov Identifier:
NCT05428111
Other Study ID Numbers:
  • Soh-Med-22-06-10
First Posted:
Jun 22, 2022
Last Update Posted:
Jun 22, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 22, 2022