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临床试验/NCT07162532
NCT07162532尚未招募不适用

Impact of Clinico-hematological and Molecular Characteristics on Treatment Outcomes of Chronic Lymphocytic Leukemia Patients

Assiut University0 个研究点目标入组 45 人开始时间: 2025年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
45
主要终点
1)A detailed profile of genetic characteristics in CLL patients . 2)Identification of relation between IGHV Mutation and treatment response.(complete remission,partial remission,stable disease,progressive disease and minimal residual disease response)

研究概览

简要总结

the goal of this study is To describe the clinical, hematologic, and cytogenetic characteristics of CLL cases.

The main questions it aims to answer are:

  1. what is the impact of cytogenetics abnormalities [e.g., IGHV mutation status, del(17p)] on patients' treatment response?
  2. what is th correlation between clinical and hematological characteristic with patients' outcome.

All participants will be subjected to history taking , Physical examination. and Laboratory investigations (Complete blood picture Cytogenetic profiles: del(17p) molecular study :IGHV mutation status).

详细描述

Chronic Lymphocytic Leukemia (CLL) is a CD 5 positive hematological malignancy that is characterized by the excess accumulation of small, mature appearing neoplastic B lymphocytes in the blood, marrow, and other lymphoid tissues, resulting in lymphocytosis, leukemia cell infiltration of the marrow, lymphadenopathy, and splenomegaly. Clonal B lymphocytes with a distinctive immunophenotype where B-cell markers (CD19, CD23) are expressed along with CD5, with low-level expression of CD20 and surface immunoglobulins . CLL is more common in men than women, and its incidence varies geographically, with higher rates reported in Western countries [5]. Clinical characteristics in the form of organomegaly and lymphadenopathy in addition to hematological characteristics in the form of lymphocytosis and cytopenia affect disease coarse and patients' outcome .The clinical course of CLL is highly variable, ranging from indolent disease that may never require treatment to aggressive forms that necessitate prompt intervention. Some patients may remain asymptomatic for many years, while others may experience symptoms such as fatigue, weight loss, and recurrent infections due to immune dysfunction . Cytogenetic and molecular genetic studies have identified a range of genetic abnormalities in CLL, including deletions, translocations, and mutations . These genetic alterations can affect the behavior of the disease and influence treatment outcomes.

Recently immunological (flowcytometry), and cytogenetic characters namely deletion 17p and immunoglobulin heavy chain gene (IgVH) mutation of CLL patients added more impact of patients' morbidity and response to treatment .

Recent research has focused on the development of targeted therapies for CLL, including venetoclax-based regimens and Bruton tyrosine kinase inhibitors . These agents have shown promise in improving outcomes for patients with CLL, particularly those with high-risk disease or refractory/relapsed disease .

New studies have also explored the role of novel therapies in CLL treatment, including combination regimens and immunotherapies. These approaches have shown encouraging results in early clinical trials, and may offer new options for patients with CLL. in this study we will study the impact of cytogenetics abnormalities [e.g., IGHV mutation status, del(17p)] on patients' treatment response.

A-History taking and clinical examination.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age ≥ 18 years newly diagnosed with CLL.
  • •Adequate diagnostics (flowcytometry and cytogenetics) and follow-up data (at least 1 year).
  • •Patients giving informed consent.

排除标准

  • •Incomplete diagnostics (e.g. flowcytometry of cytogenetics)
  • •Lost to follow-up within 12 months of diagnosis.
  • •Refused to give informed consent

结局指标

主要结局

1)A detailed profile of genetic characteristics in CLL patients . 2)Identification of relation between IGHV Mutation and treatment response.(complete remission,partial remission,stable disease,progressive disease and minimal residual disease response)

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

sawsan abdelllah

specialist of clinical hematology

Assiut University

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