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

NCT ID: NCT05428111

Last Updated: 2022-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-31

Study Completion Date

2023-08-31

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 .

Detailed Description

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Conditions

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Acute Lymphoblastic Leukemia in Pediatric

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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control

healthy control individuals

Group Type ACTIVE_COMPARATOR

flow cytometric immunophynotyping

Intervention Type DIAGNOSTIC_TEST

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

case

Newly diagnosed and under treatment cases of acute lymphoblastic leukemic

Group Type ACTIVE_COMPARATOR

flow cytometric immunophynotyping

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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flow cytometric immunophynotyping

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

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Nada Mohamed Rafat

resident doctor at clinical pathology department at sohag oncology center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Nada M Rafat, resident

Role: CONTACT

01001857100

Ahmed A Allam, assisstant professor

Role: CONTACT

01001636593

Facility Contacts

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Osama R Elshrif, professor

Role: primary

References

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Taghiloo S, Asgarian-Omran H. Immune evasion mechanisms in acute myeloid leukemia: A focus on immune checkpoint pathways. Crit Rev Oncol Hematol. 2021 Jan;157:103164. doi: 10.1016/j.critrevonc.2020.103164. Epub 2020 Nov 18.

Reference Type BACKGROUND
PMID: 33271388 (View on PubMed)

Bergman PJ, Clifford CA. Recent Advancements in Veterinary Oncology. Vet Clin North Am Small Anim Pract. 2019 Sep;49(5):xiii-xiv. doi: 10.1016/j.cvsm.2019.06.001. No abstract available.

Reference Type BACKGROUND
PMID: 31345517 (View on PubMed)

Woo JS, Alberti MO, Tirado CA. Childhood B-acute lymphoblastic leukemia: a genetic update. Exp Hematol Oncol. 2014 Jun 13;3:16. doi: 10.1186/2162-3619-3-16. eCollection 2014.

Reference Type BACKGROUND
PMID: 24949228 (View on PubMed)

Chiaretti S, Vitale A, Cazzaniga G, Orlando SM, Silvestri D, Fazi P, Valsecchi MG, Elia L, Testi AM, Mancini F, Conter V, te Kronnie G, Ferrara F, Di Raimondo F, Tedeschi A, Fioritoni G, Fabbiano F, Meloni G, Specchia G, Pizzolo G, Mandelli F, Guarini A, Basso G, Biondi A, Foa R. Clinico-biological features of 5202 patients with acute lymphoblastic leukemia enrolled in the Italian AIEOP and GIMEMA protocols and stratified in age cohorts. Haematologica. 2013 Nov;98(11):1702-10. doi: 10.3324/haematol.2012.080432. Epub 2013 May 28.

Reference Type BACKGROUND
PMID: 23716539 (View on PubMed)

Allam AA, Ahmed HA, Hassan MA, Khaled SAA, Shibl A, Osman AM, Ali NMR, Ahmed NM. Programmed Cell Death-1 and Programmed Cell Death Ligand-1 in Childhood Acute B-Lymphoblastic Leukemia: Expression and Significance as Biomarker. Int J Lab Hematol. 2025 Oct;47(5):832-839. doi: 10.1111/ijlh.14472. Epub 2025 Apr 1.

Reference Type DERIVED
PMID: 40166836 (View on PubMed)

Other Identifiers

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Soh-Med-22-06-10

Identifier Type: -

Identifier Source: org_study_id

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