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Study on Human Normal Immunoglobulin and Sodium Chloride to Prevent Infections in Patients with Chronic Lymphocytic Leukemia

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients with certain types of blood cancers, specifically B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma. These conditions can lead to a weakened immune system, making patients more prone to infections. The study is testing a treatment called Xembify, which is a form of Human Normal Immunoglobulin. This is a substance derived from blood that helps boost the immune system. The trial will compare the effects of Xembify combined with standard medical treatment to a placebo combined with standard medical treatment. The goal is to see if Xembify can help reduce the number of serious infections in these patients.

Participants in the study will receive weekly injections of either Xembify or a placebo for a period of one year. The injections are given under the skin, a method known as subcutaneous injection. Throughout the study, researchers will monitor the participants to track the number of major bacterial infections they experience. The study aims to determine if Xembify can lower the rate of these infections compared to the placebo.

The trial will also look at other factors, such as how long it takes for the first major infection to occur, the total number of infections, and the number of days participants need antibiotics. Additionally, the study will record any hospitalizations due to infections. By gathering this information, researchers hope to better understand the potential benefits of Xembify for patients with these blood cancers and weakened immune systems.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to sign an informed consent form. This document confirms your understanding of the study and your agreement to participate.
You must meet specific criteria, including being 18 years or older, having a confirmed diagnosis of B-cell chronic lymphocytic leukemia, and having low levels of immunoglobulin G (IgG).
Step 2
Initial assessment
An initial assessment will be conducted to evaluate your health status. This may include a review of your medical history and a physical examination.
Your eligibility will be confirmed based on your medical history, including any previous severe or recurrent bacterial infections.
Step 3
Treatment phase
During the treatment phase, you will receive either **Xembify** or a placebo, in addition to standard medical treatment. **Xembify** is a solution for injection administered under the skin (subcutaneous).
The treatment will be administered weekly over a one-year period. The goal is to reduce the rate of major bacterial infections.
Step 4
Monitoring and follow-up
Throughout the study, your health will be closely monitored. This includes regular check-ups to assess the effectiveness and safety of the treatment.
You will be asked to report any infections or side effects you experience. This information is crucial for evaluating the treatment's impact.
Step 5
Completion of the study
At the end of the one-year treatment period, a final assessment will be conducted to evaluate your overall health and the outcomes of the study.
The results will contribute to understanding the effectiveness of **Xembify** in preventing infections in patients with conditions like yours.

Who can join the trial?

6 criteria

Participants must be 18 years of age or older.
Participants must have a confirmed diagnosis of B-cell chronic lymphocytic leukemia (CLL). This is a type of cancer that affects certain white blood cells.
Participants must have low levels of immunoglobulin G (IgG), which is a type of antibody, with levels less than 4 grams per liter (g/L).
Participants must have a RAI stage of intermediate (1 and 2) or high (3 and 4). RAI staging is a way to describe the extent of CLL.
Participants must have a history of at least one severe bacterial infection or at least three recurrent bacterial infections in the past year. Severe infections are those that are classified as Grade 3 or higher according to a standard scale used to measure the severity of side effects.
Participants must have signed an informed consent form, which means they agree to participate in the study after being informed about all aspects of the trial.

Who cannot join the trial?

8 criteria

Patients who have a different type of cancer other than chronic lymphocytic leukemia (a type of blood cancer).
Patients who have had a major bacterial infection in the past month.
Patients who are currently receiving treatment that might interfere with the study.
Patients who have a known allergy to the study medication or its ingredients.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial in the last 30 days.
Patients who have a medical condition that the study doctors believe would make it unsafe for them to participate.
Patients who are unable to follow the study procedures or attend the required visits.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Verified
Budapest, Hungary
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Verified
Gyor, Hungary
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Responsive
Plovdiv, Bulgaria

Trial locations

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Investigated drugs

XEMBIFY is a medication used in this clinical trial to help prevent infections in patients with certain types of blood cancers, such as B-cell chronic lymphocytic leukemia, multiple myeloma, and non-Hodgkin lymphoma. It is given to patients who have low levels of antibodies, which are proteins in the blood that help fight infections. XEMBIFY is a type of immunoglobulin therapy, which means it provides extra antibodies to help the body fight off infections more effectively. In this trial, XEMBIFY is used alongside standard medical treatments to see if it can reduce the number of serious bacterial infections in these patients over a year.

What is already known about the treatment

XEMBIFY – XEMBIFY is administered as a subcutaneous injection, meaning it is given under the skin. It is currently being studied in clinical trials to assess its effectiveness and safety in preventing infections in patients with low levels of antibodies, a condition known as hypogammaglobulinemia, associated with chronic lymphocytic leukemia, multiple myeloma, and non-Hodgkin lymphoma. The main therapeutic use of XEMBIFY is to reduce the rate of major bacterial infections in these patients. At the molecular level, XEMBIFY works by providing the body with immunoglobulins, which are proteins that help the immune system fight infections. It is classified as an immunoglobulin replacement therapy.

Investigated diseases

Chronic lymphocytic leukemia – Chronic lymphocytic leukemia is a type of cancer that affects the blood and bone marrow. It typically progresses slowly and is characterized by the accumulation of abnormal lymphocytes, a type of white blood cell, in the blood. Over time, these abnormal cells can crowd out healthy blood cells, leading to symptoms such as fatigue, swollen lymph nodes, and frequent infections. As the disease advances, it may cause anemia, bleeding problems, and an increased risk of infections due to the immune system's impaired function. The progression of chronic lymphocytic leukemia can vary greatly among individuals, with some experiencing a slow course and others a more rapid progression.