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Chronic Lymphocytic LeukemiaNCT06475469

Description of the Immune Deficiency in Patients With Untreated Chronic Lymphocytic Leukemia and Search for Predictive Factors of Infectious Risk

A study testing Blood sampling & Chest CT without injection in people with Chronic Lymphocytic Leukemia, run by CHU de Reims at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
Blood sampling & Chest CT without injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteFrance
Study dates
10 May 2022to Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Untreated CLL patients
  • Patients > 18 years of age
  • Patients agreing to participate to the study
  • Patients inured under the french social security system

Who cannot join

  • Previously treated CLL patients
  • Patients protected by law

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Anne QUINQUENEL, Pr. contact

03.26.78.74.76

aquinquenel@chu-reims.fr

Amélie SERVETTAZ, Pr. contact

03.26.83.27.69

aservettaz@chu-reims.fr

France1 site, 1 recruiting
  • Chu Reims

    Reims, 51092

    Damien JOLLY, Pr., 326788472 ext. 33, djolly@chu-reims.fr

    Recruiting

Other trials in France

About this study

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.

Read the 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.

Being tested
Blood sampling & Chest CT without injection
Keywords
Chronic Lymphocytic Leukemia, Immunodeficiency, Lymphocyte subpopulations, Bronchiectasis
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Immunologic Deficiency Syndromes, Bronchiectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood sampling & Chest CT without injectionBiological

    Anlaysis of the repartition of non-tumorous lymphocytic subpopulation in patients with untreated Chronic Lymphocytic Leukemia (CLL)

Study groups in NCT06475469
Study groupRoleWhat they receive
Patients with untreated Chronic Lymphocytic Leukemia (CLL)OtherNot described
Receives: Biological: Blood sampling & Chest CT without injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immunophenotyping

    Description of some circulating B and T cell subsets

    Measured: At inclusion

Secondary outcomes (1)
  1. Bronchectasies

    presence of bronchiectasis (Non-contrast thin section thoracic CT-scan allowing to detect the ) and if present the severity index (Bhalla score)

    Measured: At inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2024
  2. Study start10 May 2022
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06475469
Sponsor's protocol ID
PO22063
Status last verified
Jun 2024
First submitted
13 Jun 2024
Last updated
26 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Blood sampling & Chest CT without injection in people with Chronic Lymphocytic Leukemia, run by CHU de Reims at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anne QUINQUENEL, Pr. (03.26.78.74.76, aquinquenel@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immunophenotyping (time frame: At inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.

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