Description of the Immune Deficiency in Patients With Untreated Chronic Lymphocytic Leukemia and Search for Predictive Factors of Infectious Risk
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2022
CompletedFirst Submitted
Initial submission to the registry
June 13, 2024
CompletedFirst Posted
Study publicly available on registry
June 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
June 26, 2024
June 1, 2024
6.1 years
June 13, 2024
June 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Immunophenotyping
Description of some circulating B and T cell subsets
At inclusion
Secondary Outcomes (1)
Bronchectasies
At inclusion
Study Arms (1)
Patients with untreated Chronic Lymphocytic Leukemia (CLL)
OTHERInterventions
Anlaysis of the repartition of non-tumorous lymphocytic subpopulation in patients with untreated Chronic Lymphocytic Leukemia (CLL)
Eligibility Criteria
You may qualify if:
- Untreated CLL patients
- Patients \> 18 years of age
- Patients agreing to participate to the study
- Patients inured under the french social security system
You may not qualify if:
- Previously treated CLL patients
- Patients protected by law
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CHU de Reimslead
Study Sites (1)
Chu Reims
Reims, 51092, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2024
First Posted
June 26, 2024
Study Start
May 10, 2022
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
June 26, 2024
Record last verified: 2024-06