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
About this trial
This is an interventional diagnostic trial for Acute Lymphoblastic Leukemia
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.
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
NCT ID
NCT04554381
First Posted
September 14, 2020
Last Updated
September 17, 2020
Sponsor
Assiut University
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
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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
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Assesment of JL1 Expression in Acute Leukemia
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