Immunophenotypic Evaluation of IL-7R α in Acute Leukaemia

November 30, 2022 updated by: Rania Abdeltwab Abdelazeim

Acute leukemia is generally understood to be a neoplastic process that exerts a maturational block at a hematopoietic precursor cell level, accompanied by a proliferative drive of varying degree. The resulting accumulation of cells, most frequently in the marrow, causes the typical clinical picture, which includes marrow failure, tissue infiltration, organomegaly and on occasion, tumor masses. AL is broadly classified as acute myeloid leukemia (AML) and acute lymphoid leukemia (ALL) (1).

Acute lymphoblastic leukemia is frequently diagnosed in children and young adults, with incidence peaks between 2 and 5 years of age (2), whereas AML is the most common acute type in adults (3).

In addition to leukemia cells themselves, cells of the immune system are a fundamental component of the tumor microenvironment (TME), which often modify the TME to be more favorable to tumor development and progression through producing cytokines and mediators (4,5) . Interleukins / interleukin receptors interaction plays important roles in the antitumor immune response through mediating cell-cell communication in TME and is reported to be relevant to patient prognosis (6,7). As a member of the Interleukin family, Interleukin 7 (IL7) play vital roles in hematopoiesis and the development of T lymphocytes, as well as the inflammation, autoimmune diseases and hematological cancers. Its function is mediated by the IL7 R, which is a membrane receptor consisted of the specific IL7Ra chain (CD127) and IL-7Rγ chain (common gamma chain shared by the receptors for IL-2,-4,-9,-15, and-21) (8). It is thus not surprising that activation of IL-7 signalling is seen in the majority of T-ALLs and in some of the B cell precursor ALL (9,10).

Consistent with the absolute requirement of IL-7 to human T cell development, most T-ALLs have been shown to respond to IL-7. Thus targeting IL-7 signaling might be a reasonable general approach for treatment of T-ALL, regardless the presence of activating mutations. (10)

Study Overview

Detailed Description

Acute leukemia is generally understood to be a neoplastic process that exerts a maturational block at a hematopoietic precursor cell level, accompanied by a proliferative drive of varying degree. The resulting accumulation of cells, most frequently in the marrow, causes the typical clinical picture, which includes marrow failure, tissue infiltration, organomegaly and on occasion, tumor masses. AL is broadly classified as acute myeloid leukemia (AML) and acute lymphoid leukemia (ALL) (1).

Acute lymphoblastic leukemia is frequently diagnosed in children and young adults, with incidence peaks between 2 and 5 years of age (2), whereas AML is the most common acute type in adults (3).

In addition to leukemia cells themselves, cells of the immune system are a fundamental component of the tumor microenvironment (TME), which often modify the TME to be more favorable to tumor development and progression through producing cytokines and mediators (4,5) . Interleukins / interleukin receptors interaction plays important roles in the antitumor immune response through mediating cell-cell communication in TME and is reported to be relevant to patient prognosis (6,7). As a member of the Interleukin family, Interleukin 7 (IL7) play vital roles in hematopoiesis and the development of T lymphocytes, as well as the inflammation, autoimmune diseases and hematological cancers. Its function is mediated by the IL7 R, which is a membrane receptor consisted of the specific IL7Ra chain (CD127) and IL-7Rγ chain (common gamma chain shared by the receptors for IL-2,-4,-9,-15, and-21) (8). It is thus not surprising that activation of IL-7 signalling is seen in the majority of T-ALLs and in some of the B cell precursor ALL (9,10).

Consistent with the absolute requirement of IL-7 to human T cell development, most T-ALLs have been shown to respond to IL-7. Thus targeting IL-7 signaling might be a reasonable general approach for treatment of T-ALL, regardless the presence of activating mutations. (10).

Study Type

Observational

Enrollment (Anticipated)

83

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

- Newly diagnosed patients with Acute leukemia (ALL, AML), male or female at any age will be investigated for Immunophenotypic expression of IL7R α and its diagnostic value.

Description

Inclusion Criteria:

  • Newly diagnosed patients with Acute leukemia (ALL, AML), male or female at any age.

Exclusion Criteria:

  • Patients diagnosed with hematological malignancy other than acute leukemias
  • Patients receiving chemo and/or radiotherapy
  • Patients on steroid therapy for any other reason
  • Patients receiving any immunosuppressive drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunophenotypic expression of IL7R α in acute leukemia cases.
Time Frame: 2022-2024
Immunophenotypic expression of IL7R α in acute leukemia cases.
2022-2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

October 30, 2024

Study Registration Dates

First Submitted

November 30, 2022

First Submitted That Met QC Criteria

November 30, 2022

First Posted (Estimate)

December 8, 2022

Study Record Updates

Last Update Posted (Estimate)

December 8, 2022

Last Update Submitted That Met QC Criteria

November 30, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 159159

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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