Acute Lymphoblastic Leukemia in PediatricNCT05428111
Expression of Programmed Death-1 (PD-1) & Programmed Death Ligand-1 (PDL-1) in Acute Lymphoblastic Leukemia in Pediatric
A study testing flow cytometric immunophynotyping in people with Acute Lymphoblastic Leukemia in Pediatric, run by Sohag University at 1 site in Egypt.
Trial 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). . Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia in Pediatric
- What is being tested?
- flow cytometric immunophynotyping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2022to Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age range from 1 day to 18 years old
- Patients who are newly diagnosed and under treatment of acute lymphoblastic leukemia
Who cannot join
- Other types of acute leukemia rather than acute lymphoblastic leukemia
Trial locations and contacts
1 site in 1 country.
Ahmed A Allam, assisstant professor contact
About this study
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). .
Read more
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 .
- Being tested
- flow cytometric immunophynotyping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flow cytometric immunophynotypingDiagnostic test
Expression of programmed death-1 (PD-1) \& programmed death ligand-1 (PDL-1) in flow cytometric immunophynotyping
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | healthy control individuals Receives: Diagnostic Test: flow cytometric immunophynotyping |
| case | Active comparator | Newly diagnosed and under treatment cases of acute lymphoblastic leukemic Receives: Diagnostic Test: flow cytometric immunophynotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
programmed death-1 (PD-1) by flow cytometry immunophynotyping
Assess programmed death-1 by flow cytometry immunophynotyping
Measured: 6 months
Programmed death ligand -1 (PDL-1) by flow cytometry immunophynotyping
Assess programmed death ligand -1 by flow cytometry immunophynotyping
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study startAug 2022 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic Leukemia in PediatricStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Mohamed Rafat, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428111
- Sponsor's protocol ID
- Soh-Med-22-06-10
- Status last verified
- Jun 2022
- First submitted
- 15 Jun 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33271388Bergman 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.
PubMed 31345517Woo 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.
PubMed 24949228Chiaretti 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.
PubMed 23716539Allam 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.
PubMed 40166836
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Programmed Death-1 (PD-1) & Programmed Death Ligand-1 (PDL-1) in Acute Lymphoblastic Leukemia in Pediatric
- ClinicalTrials.gov ID
- NCT05428111
- Acronym / sponsor ID
- Soh-Med-22-06-10
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Aug 2022 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Diagnostic Test: flow cytometric immunophynotypinghealthy control individuals |
| case | Active comparator | Diagnostic Test: flow cytometric immunophynotypingNewly diagnosed and under treatment cases of acute lymphoblastic leukemic |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age range from 1 day to 18 years old
- Patients who are newly diagnosed and under treatment of acute lymphoblastic leukemia
Key exclusion criteria (1 listed)
- Other types of acute leukemia rather than acute lymphoblastic leukemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flow cytometric immunophynotypingExpression of programmed death-1 (PD-1) \& programmed death ligand-1 (PDL-1) in flow cytometric immunophynotyping | Diagnostic test | case, control |
Primary outcome
programmed death-1 (PD-1) by flow cytometry immunophynotyping
Time frame: 6 months
Assess programmed death-1 by flow cytometry immunophynotyping
Programmed death ligand -1 (PDL-1) by flow cytometry immunophynotyping
Time frame: 6 months
Assess programmed death ligand -1 by flow cytometry immunophynotyping
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Background: PubMed 33271388Taghiloo 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.
- Background: PubMed 31345517Bergman 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.
- Background: PubMed 24949228Woo 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.
- Background: PubMed 23716539Chiaretti 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.
- Derived from this study: PubMed 40166836Allam 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.
Related trials for Acute Lymphoblastic Leukemia in Pediatric
Active, not recruitingPhase 2
Study of Blinatumomab Administration in Chinese Pediatric Participants With Relapsed/Refractory B Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)
B Precursor Acute Lymphoblastic Leukemia, Relapsed/Refractory B Precursor Acute Lymphoblastic Leukemia
RecruitingPhase 1/2
Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01)
B-cell Acute Lymphoblastic Leukemia, Diffuse Large B-cell Lymphoma
RecruitingPhase 1/2
Phase I/II Trial: Engineered Donor Graft (Orca Q) for Pediatric Hematopoietic Cell Transplant (HCT)
Acute Myeloid Leukemia, Acute Lymphoid Leukemia
RecruitingObservational study
Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution
Hematologic Malignancy, Leukemia
Recruiting
Hospital Based Continuous Patient Monitoring System
Trauma, Appendectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed A Allam, assisstant professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flow cytometric immunophynotyping in people with Acute Lymphoblastic Leukemia in Pediatric, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nada M Rafat, resident (01001857100, nada011207@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
programmed death-1 (PD-1) by flow cytometry immunophynotyping (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05428111, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.