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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05428111
Enrollment
50
Registered
2022-06-22
Start date
2022-08-31
Completion date
2023-08-31
Last updated
2022-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia in Pediatric

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 .

Interventions

DIAGNOSTIC_TESTflow cytometric immunophynotyping

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

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 18 Years
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

Design outcomes

Primary

MeasureTime frameDescription
programmed death-1 (PD-1) by flow cytometry immunophynotyping6 monthsAssess programmed death-1 by flow cytometry immunophynotyping
Programmed death ligand -1 (PDL-1) by flow cytometry immunophynotyping6 monthsAssess programmed death ligand -1 by flow cytometry immunophynotyping

Countries

Egypt

Contacts

Primary ContactNada M Rafat, resident
nada011207@med.sohag.edu.eg01001857100
Backup ContactAhmed A Allam, assisstant professor
01001636593

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026