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Assesment of JL1 Expression in Acute Leukemia

2020年9月17日 更新者:Zeinab Galal Eldeen Abdelhamid、Assiut University

Assesment of JL1 Expression in B-cell Acute Lymphoblastic Leukemia

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.

研究概览

地位

尚未招聘

详细说明

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.

研究类型

介入性

注册 (预期的)

50

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:非随机化
  • 介入模型:顺序分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:JL1
JL1 on acute leukemia
we hypothesis that JL1 can be used as an adjunctive marker for the initial diagnosis and the follow up of Acute Lymphoblastic Leukemia.
实验性的:JL1 and acute leukemia
Assesment of JL1 expression on acute leukemia
we hypothesis that JL1 can be used as an adjunctive marker for the initial diagnosis and the follow up of Acute Lymphoblastic Leukemia.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Evaluation and assessment of JL1 expression in B-cell Acute Lymphoblastic Leukemia.
大体时间:Baseline
Correlatin of this marker with clinical, morphological, immunophenotypic, cytogenetic data and response to treatment.
Baseline

合作者和调查者

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出版物和有用的链接

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研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2020年10月13日

初级完成 (预期的)

2023年10月1日

研究完成 (预期的)

2023年11月1日

研究注册日期

首次提交

2020年9月14日

首先提交符合 QC 标准的

2020年9月17日

首次发布 (实际的)

2020年9月18日

研究记录更新

最后更新发布 (实际的)

2020年9月18日

上次提交的符合 QC 标准的更新

2020年9月17日

最后验证

2020年9月1日

更多信息

与本研究相关的术语

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研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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