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临床试验/NCT03971565
NCT03971565Unknown不适用

Evaluation of the Redox Profiles of Healthy and Pathological B Cells in Patients With Chronic Lymphocytic Leukemia

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2019年3月19日最近更新:
适应症

试验速览

阶段
不适用
入组人数
47
试验地点
1
主要终点
Differentiate tumor B lymphocytes from normal B cells

研究概览

简要总结

In recent years, considerable progress has been made in understanding the biology of chronic lymphocytic leukemia (CLL), resulting in the emergence of new therapeutic agents that have significantly improved the long-term survival of patients. However, LLC is still considered an incurable disease.

Cytogenetic abnormalities are frequently found in this pathology. Some abnormalities are associated with a more aggressive disease and a poor prognosis. The deletion of chromosome 17p (del (17p)), in particular, makes leukemic cells more resistant to standard therapy. Chromosome 17p contains the Tumor Protein 53 gene (TP53) which encodes the tumor suppressor protein 53 (P53) protein. P53 plays a central role in the regulation of important cellular functions such as DNA damage response, cell cycle regulation, apoptosis, and drug sensitivity of chemotherapies. In patients with CLL, the loss of p53 function is a major factor of chemoresistance and is associated with an adverse prognosis. The deletion (17p) is observed in approximately 5 to 10% of patients with CLL. In contrast, mutations in the TP53 gene are observed in approximately 30% of patients with CLL. This means that about one-third of patients with CLL have p53 dysfunction. TP53 and / or del (17p) mutated LLC cells show marked mitochondrial dysfunction. This dysfunction is responsible for a deregulation of intracellular redox phenomena, leading to an increase in oxidative stress and an overproduction of reactive oxygen derivatives (ROS).

Dimethyl Ampal Thiolester (DIMATE) is an active, competitive and irreversible inhibitor of aldehyde dehydrogenases (ALDH) 1 and 3. In vitro, DIMATE eradicates human cells from acute myeloblastic leukemia (AML). In patients with CLL, current treatments, particularly effective, do not specifically target pathological B cells. This results in chronic B lymphopenia and hypogammaglobulinemias that provide severe long-term infections, which is the leading cause of death in patients with CLL.

Through this study, we will study, in vitro, the expression of ALDH 1, 3, 9 but also of glutathione (GSH) and ROS on tumor B lymphocytes and healthy patients carrying an LLC. Depending on the differences in expression observed, DIMATE could specifically eradicate leukemic lymphocyte cells by sparing healthy lymphocytes, a hypothesis that will be tested in vitro. A special evaluation will be made in patients with del (17) and / or TP53 mutation whose prognosis is still considered unfavorable despite new therapeutic advances.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • Major patient (greater than or equal to 18 years)
  • Patients with 4 to 5 (or equivalent) grade 4 or 5 Matheol Score-confirmed chronic lymphocytic leukemia (CLL), whether prior to treatment or relapse
  • For relapsed patients of their CLL, a minimum period of 90 days without treatment (including corticosteroids) compared to previous chemotherapy
  • Patient having received the information and having given his non-opposition

排除标准

  • Previous chemotherapy treatment outside of previous CLL therapy
  • Active secondary cancer currently being treated with the exception of non-melanoma skin cancer or cervical cancer in situ
  • Transformation into high grade lymphoma, Richter syndrome or pro-lymphocytic leukemia,
  • Viral or fungal bacterial infection active at the time of screening Infection with human immunodeficiency virus,
  • Medical or psychological condition that could interact with the ability to understand the study

结局指标

主要结局

Differentiate tumor B lymphocytes from normal B cells

时间窗: 24 months

Marker analysis is performed by flow cytometry to determine the expression of labeled reactive oxygen derivatives (ROS) molecules on tumor lymphocytes.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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