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Assesment of JL1 Expression in Acute Leukemia

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ClinicalTrials.gov Identifier: NCT04554381
Recruitment Status : Not yet recruiting
First Posted : September 18, 2020
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Zeinab Galal Eldeen Abdelhamid, Assiut University

Study Description
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Brief Summary:
The aim of this study is to assess JL1 expression by flow cytometric immunophenotyping in patients with B-cell Acute Lymphoblastic Leukemia (ALL) and to correlate it with clinical, morphological, immunophenotypic, cytogenetic data and response to treatment.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Biological: JL1 antigen Phase 1

Detailed Description:

Acute Lymphoblastic Leukemia (ALL) is characterized by a rapidly progressive disease. It accounts for approximately 75% of all cases of childhood leukemias, that produces large and immature cells (20% or more lymphoblasts in the bone marrow (BM) and/or the blood) that can't carry out their normal BM function (Terwilliger and Abdul-Hay, 2017).

The main cause of ALL lies in the genetic or acquired injury to DNA of a single cell in the BM with the presence of risk factors such as radiation, benzene exposure, Down syndrome and past treatment with chemotherapeutic agents which leads to uncontrolled and exaggerated growth and accumulation of lymphoblasts which fail to function as normal blood cells. This results in blocking the production of normal blood cells and leads to anemia, thrombocytopenia and neutropenia. The most frequent signs are lymphadenopathies, hepatosplenomegaly, fever, anemia, signs of hemorrhage, and bone tenderness.

The prognostic factors of ALL include patients' factors such as age, white blood cell (WBC) count and genetic factors such as chromosome and gene changes along with the immunophenotypic characteristics of the leukemic blast cells and the individual response to therapy.

JL1 is a CD43 epitope and mucin family cell surface glycoprotein that is expressed on leukemic cells. It is expressed on hematopoietic cells at different stages of differentiation including early stage lymphoid precursors and late stage of myeloid cells. Expression patterns of JL1 antigen occurs on cell surface of leukemic cells, BM cells and phytohemagglutinin (PHA)-activated lymphocytes. Most leukemic cells usually express JL1 even in weak positive cases.

JL1 is usually expressed in about 60% of acute leukemia regardless of the lineage. It was also detected on CD34+ CD10+ lymphoid precursors and some immature myeloid cells in BM. An anti-JL1 (a monoclonal antibody that is selectively reactive with antigen in spite of the differences in the molecular weight) is mixed with a toxic substance that target the leukemic cells which leads to the emergence of its role as a therapeutic agent.

Therefore, the invistigators aim to study JL1 expression on leukemic cells in ALL patients in South Egypt Cancer Institute, as we hypothesis that it can be used as an adjunctive marker for the initial diagnosis and the follow up of ALL.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Assesment of JL1 Expression in B-cell Acute Lymphoblastic Leukemia
Estimated Study Start Date : October 13, 2020
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: JL1
JL1 on acute leukemia
 Biological: JL1 antigen
we hypothesis that JL1 can be used as an adjunctive marker for the initial diagnosis and the follow up of Acute Lymphoblastic Leukemia.
Experimental: JL1 and acute leukemia
Assesment of JL1 expression on acute leukemia
 Biological: JL1 antigen
we hypothesis that JL1 can be used as an adjunctive marker for the initial diagnosis and the follow up of Acute Lymphoblastic Leukemia.


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation and assessment of JL1 expression in B-cell Acute Lymphoblastic Leukemia. [ Time Frame: Baseline ]
    Correlatin of this marker with clinical, morphological, immunophenotypic, cytogenetic data and response to treatment.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients with newly diagnosed B-cell ALL.
  2. Age group: both pediatric patients (< 18 years old) and adult patients (> 18 years old) will be included in our study.

Exclusion Criteria:

1. Patients with other types of hematologic neoplasms. 2 .Relapsed patients.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04554381


Contacts
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Contact: Zeinab Galal, medical resident +201094838810 zeinab_gatasalva@yahoo.com
Contact: Douaa Mohamed, Professor +201006261987 Douaa_sayed@hotmail.com

Sponsors and Collaborators
Assiut University
More Information
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Publications:

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Responsible Party: Zeinab Galal Eldeen Abdelhamid, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT04554381    
Other Study ID Numbers: JL1 in Acute Leukemia
First Posted: September 18, 2020    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases