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CD155 Expression in Acute Myeloid Leukemia

Study Purpose

Acute myeloid leukemia (AML) is a heterogeneous hematologic malignancy. It is the most common form of acute leukemia among adults. In the United States, an estimated 19,940 people will be diagnosed with AML in 2020. CD155 expression was associated with an unfavorable prognosis in solid tumors such as colon cancer, breast cancer, lung adenocarcinoma, pancreatic cancer, melanoma, and glioblastoma, as it correlated with tumor migration, development of metastases, tissue and lymph node invasion, relapse, and poorer survival.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years - 60 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients with newly diagnosed AML.
  • - Age group: patients more than 18 years old and less than 60 years.
  • - Patients receiving induction chemotherapy 3&7 at South Egypt Cancer Institute.

Exclusion Criteria:

  • - Patients less than 18 years old and over 60 years.
  • - Patients with concurrent malignancy.
  • - Secondary AML.
  • - Acute Promyelocytic leukemia (AML-M3).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06369662
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Assiut University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Nehal Rayan, M.D.
Principal Investigator Affiliation Assistant Lecturer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Completed
Countries Egypt
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Neoplasms, Hematologic Neoplasms, Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute
Additional Details

Acute myeloid leukemia (AML) is a heterogeneous hematologic malignancy. It is the most common form of acute leukemia among adults. In the United States, an estimated 19,940 people will be diagnosed with AML in 2020. T-cell exhaustion is a state of decline in T-cell proliferation and function (secretion of cytokines and cytotoxicity). It is defined by the expression of immune checkpoints including programmed cell death protein-1 (PD1), cytotoxic T-lymphocyte-associated protein-4 (CTLA4), T-cell immunoglobulin and mucin-domain containing-3 (TIM3), lymphocyte-activation gene-3 (LAG3), T-cell immunoreceptor with immunoglobulin and ITIM domains (TIGIT), and CD160. This phenomenon was observed in many cancer cells to escape from antitumor immune responses. The poliovirus receptor (PVR), also known as CD155, is an immunoglobulin -like adhesion molecule, with an important regulatory role in T-cell and natural killer (NK) cell functions, cell migration and proliferation. It is a major ligand that is expressed on epithelial and myeloid cells of the tumor. PVR is able to bind CD226, DNAX accessory molecule-1 (DNAM-1), T-cell-Activated Increased Late Expression Protein (TACTILE), and TIGIT. Binding to DNAM-1 induces the release of pro-inflammatory cytokines and cytotoxicity of T-cells and NK cells (T-cell activation), while binding to TIGIT induces a rather anti-inflammatory, non-proliferative, and noncytotoxic profile (T-cell exhaustion). CD155 expression was associated with an unfavorable prognosis in solid tumors such as colon cancer, breast cancer, lung adenocarcinoma, pancreatic cancer, melanoma, and glioblastoma, as it correlated with tumor migration, development of metastases, tissue and lymph node invasion, relapse, and poorer survival. Stamm et al., demonstrated that high CD155 (PVR) expression correlated with poor outcome in AML. Stamm et al., also showed that antibody blockade of PVR on AML cell lines or primary AML cells or TIGIT blockade on immune cells increased the anti-leukemic effects mediated by purified CD3+ cells in vitro. Zhang et al., assessed the prognostic significance and immune-associated mechanism of CD155 and identified that CD155 was commonly upregulated in most human cancers including AML, and high expression of CD155 was closely correlated with unfavorable clinical outcomes. Our aim is to study the prognostic and predictive values of CD155 expression in AML patients in our locality.

Arms & Interventions

Arms

: AML Patients

Adult patients (from 18 - 60 years) diagnosed as AML

Interventions

Diagnostic Test: - Flow cytometric immunophenotyping

CD155 expression by flow cytometric immunophenotyping

Diagnostic Test: - Complete blood count

Complete blood count with peripheral blood smear examination

Diagnostic Test: - Bone marrow aspiration

Bone marrow aspiration at both diagnosis and follow up of patients

Diagnostic Test: - Cytogenetic testing

Karyotyping or AML fluorescence in situ hybridization (FISH) panel for diagnosis and risk stratification of AML patients

Diagnostic Test: - FLT3-ITD using High resolution melting curve (HRM) analysis

Detection of FLT3-ITD mutation in AML patinets

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Assiut, Egypt

Status

Address

South Egypt Cancer Institute, Assiut University

Assiut, , 71111