Assesment of JL1 Expression in Acute Leukemia

NCT ID: NCT04554381

Last Updated: 2020-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-13

Study Completion Date

2023-11-30

Brief Summary

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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

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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.

Conditions

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Acute Lymphoblastic Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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JL1

JL1 on acute leukemia

Group Type EXPERIMENTAL

JL1 antigen

Intervention Type BIOLOGICAL

we hypothesis that JL1 can be used as an adjunctive marker for the initial diagnosis and the follow up of Acute Lymphoblastic Leukemia.

JL1 and acute leukemia

Assesment of JL1 expression on acute leukemia

Group Type EXPERIMENTAL

JL1 antigen

Intervention Type BIOLOGICAL

we hypothesis that JL1 can be used as an adjunctive marker for the initial diagnosis and the follow up of Acute Lymphoblastic Leukemia.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Zeinab Galal Eldeen Abdelhamid

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Zeinab Galal, medical resident

Role: CONTACT

+201094838810

Douaa Mohamed, Professor

Role: CONTACT

+201006261987

References

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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.

Reference Type BACKGROUND
PMID: 28665419 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20073611 (View on PubMed)

Other Identifiers

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JL1 in Acute Leukemia

Identifier Type: -

Identifier Source: org_study_id

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