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Assesment of JL1 Expression in Acute Leukemia

Primary Purpose

Acute Lymphoblastic Leukemia

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
JL1 antigen
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Lymphoblastic Leukemia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    JL1

    JL1 and acute leukemia

    Arm Description

    JL1 on acute leukemia

    Assesment of JL1 expression on acute leukemia

    Outcomes

    Primary Outcome Measures

    Evaluation and assessment of JL1 expression in B-cell Acute Lymphoblastic Leukemia.
    Correlatin of this marker with clinical, morphological, immunophenotypic, cytogenetic data and response to treatment.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 14, 2020
    Last Updated
    September 17, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04554381
    Brief Title
    Assesment of JL1 Expression in Acute Leukemia
    Official Title
    Assesment of JL1 Expression in B-cell Acute Lymphoblastic Leukemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 13, 2020 (Anticipated)
    Primary Completion Date
    October 2023 (Anticipated)
    Study Completion Date
    November 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Lymphoblastic Leukemia

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 1
    Interventional Study Model
    Sequential Assignment
    Masking
    Investigator
    Allocation
    Non-Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    JL1
    Arm Type
    Experimental
    Arm Description
    JL1 on acute leukemia
    Arm Title
    JL1 and acute leukemia
    Arm Type
    Experimental
    Arm Description
    Assesment of JL1 expression on acute leukemia
    Intervention Type
    Biological
    Intervention Name(s)
    JL1 antigen
    Intervention Description
    we hypothesis that JL1 can be used as an adjunctive marker for the initial diagnosis and the follow up of Acute Lymphoblastic Leukemia.
    Primary Outcome Measure Information:
    Title
    Evaluation and assessment of JL1 expression in B-cell Acute Lymphoblastic Leukemia.
    Description
    Correlatin of this marker with clinical, morphological, immunophenotypic, cytogenetic data and response to treatment.
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with newly diagnosed B-cell ALL. 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zeinab Galal, medical resident
    Phone
    +201094838810
    Email
    zeinab_gatasalva@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Douaa Mohamed, Professor
    Phone
    +201006261987
    Email
    Douaa_sayed@hotmail.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28665419
    Citation
    Terwilliger T, Abdul-Hay M. Acute lymphoblastic leukemia: a comprehensive review and 2017 update. Blood Cancer J. 2017 Jun 30;7(6):e577. doi: 10.1038/bcj.2017.53.
    Results Reference
    background
    PubMed Identifier
    20073611
    Citation
    Park YS, Park SH, Park SJ, Kim Y, Jang KT, Ko YH, Lee MW, Huh JR, Park CS. Expression of JL1 is an effective adjunctive marker of leukemia cutis. Arch Pathol Lab Med. 2010 Jan;134(1):95-102. doi: 10.5858/2008-0699-OAR.1.
    Results Reference
    background

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    Assesment of JL1 Expression in Acute Leukemia

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