Ignite Creation Date:
2024-07-17 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475469
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-13
Brief Title:
Description of the Immune Deficiency in Patients With Untreated Chronic Lymphocytic Leukemia and Search for Predictive Factors of Infectious Risk
Sponsor:
CHU de Reims
Organization:
CHU de Reims
Study Overview
Official Title:
Description of the Immune Deficiency in Patients With Untreated Chronic Lymphocytic Leukemia and Search for Predictive Factors of Infectious Risk
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chronic Lymphocytic Leukemia CLL is the most common adult leukemia in western countries CLL is most often discovered incidentally when a blood test carried out for another reason highlights an increase of subpopulation of white cells called lymphocytes It is also sometimes diagnosed when complications such as an increase in the size of the lymph nodes or a decrease in other blood lines red blood cells and platelets occur Its evolution is heterogeneous and only patients with symptoms require treated CLL is aso characterized by its hability to induce immunodeficiency which tends to worsen over time even in patients who do not receive any treatment Thus patients with CLL have more infections than the general population and these infectious complications are the leading cause of death Similarly vaccination whether directed against classical pathogens such as influenzae or more recently against SARS-CoV2 is less effective in patients with CLL The causes of this immune deficiency are not completely elucidated and the objective of our study is to analyze different subpopulations of lymphocytes thanks to a blood sample The investigators thus hope to be able to determine more precisely the reasons underlying these infections in order to better prevent them
Detailed Description:
Chronic Lymphocytic Leukemia CLL is a monoclonal B-cell proliferation and the most common leukemia of adults It is characterized by infiltration of the bone marrow lymph nodes and blood by small mature lymphocytes It is an incurable pathology but its evolution is extremely heterogeneous Thus some patients will have a life expectancy close to normal without treatment while for others a progression of the disease will require the introduction of a specific treatment
One of the main characteristics of CLL is the associated immune dysfunction The presence of an increased risk of infectious complications has been clearly demonstrated even in patients with indolent forms of the disease Immunosuppression is multifactorial affecting both humoral and cellular immunity Nevertheless the major abnormality associated with infectious risk in CLL is hypogammaglobulinemia Hypogammaglobulinemia is present in approximately 20 of patients at diagnosis and worsens during the course of the disease In particular it is responsible for an impaired vaccine response and the occurrence of encapsulated bacterial infections As with primary humoral immunodeficiency chronic humoral immunodeficiency secondary to CLL is associated with the development of irreversible bronchiectasis the prevalence of which is not well understood and which increases the risk of severe respiratory infectious complications
In CLL patients the normal B lymphocyte compartment and in particular certain populations of interest such as the memory B lymphocyte populations have only been studied to a limited extent Similarly there is little data on follicular helper T cells TfH cells which play a key role in the acquisition of anti-infectious and particularly post-vaccination immunity
The primary objective of this study is to analyze the distribution of non-tumor lymphocyte subpopulations in patients with untreated CLL
The secondary objectives of the research are
1 To prospectively assess the frequency and severity of infections in patients with CLL
2 To search for an association between biological and particularly immunophenotypic data and the occurrence of infections
3 To define the prevalence of bronchiectasis in CLL patients
4 To study the clinical immunological and biochemical factors associated with the presence of bronchiectasis in CLL patients
75 untreated CLL patients will be included in this study Thoracic CT scan and immunophenotyping will be performed at inclusion Infectious complications will be collected prospectively through a follow-up booklet provided to the patient at the time of inclusion All infections requiring at least one consultation with the general practitioner will be collected Reported infections will be graded according to a classification derived from the CTCAE
Our study should help to better characterize the immune deficiency associated with CLL through the analysis of lymphocyte subpopulations A better understanding of the mechanisms underlying this immune deficiency could lead to a better identification of patients at risk of infectious complications and to a better understanding of the vaccine efficacy deficit in CLL patients Finally earlier diagnosis and identification of patient profiles more likely to have bronchiectasis could allow for targeted and personalized therapeutic management and follow-up for each patient
One of the main characteristics of CLL is the associated immune dysfunction The presence of an increased risk of infectious complications has been clearly demonstrated even in patients with indolent forms of the disease Immunosuppression is multifactorial affecting both humoral and cellular immunity Nevertheless the major abnormality associated with infectious risk in CLL is hypogammaglobulinemia Hypogammaglobulinemia is present in approximately 20 of patients at diagnosis and worsens during the course of the disease In particular it is responsible for an impaired vaccine response and the occurrence of encapsulated bacterial infections As with primary humoral immunodeficiency chronic humoral immunodeficiency secondary to CLL is associated with the development of irreversible bronchiectasis the prevalence of which is not well understood and which increases the risk of severe respiratory infectious complications
In CLL patients the normal B lymphocyte compartment and in particular certain populations of interest such as the memory B lymphocyte populations have only been studied to a limited extent Similarly there is little data on follicular helper T cells TfH cells which play a key role in the acquisition of anti-infectious and particularly post-vaccination immunity
The primary objective of this study is to analyze the distribution of non-tumor lymphocyte subpopulations in patients with untreated CLL
The secondary objectives of the research are
1 To prospectively assess the frequency and severity of infections in patients with CLL
2 To search for an association between biological and particularly immunophenotypic data and the occurrence of infections
3 To define the prevalence of bronchiectasis in CLL patients
4 To study the clinical immunological and biochemical factors associated with the presence of bronchiectasis in CLL patients
75 untreated CLL patients will be included in this study Thoracic CT scan and immunophenotyping will be performed at inclusion Infectious complications will be collected prospectively through a follow-up booklet provided to the patient at the time of inclusion All infections requiring at least one consultation with the general practitioner will be collected Reported infections will be graded according to a classification derived from the CTCAE
Our study should help to better characterize the immune deficiency associated with CLL through the analysis of lymphocyte subpopulations A better understanding of the mechanisms underlying this immune deficiency could lead to a better identification of patients at risk of infectious complications and to a better understanding of the vaccine efficacy deficit in CLL patients Finally earlier diagnosis and identification of patient profiles more likely to have bronchiectasis could allow for targeted and personalized therapeutic management and follow-up for each patient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None