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Study on the Use of Human Normal Immunoglobulin for Preventing Infections in Patients with Chronic Lymphocytic Leukemia and Secondary Immunodeficiency

Fast replyRegistered drugNo placebo
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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 studying a type of cancer called Chronic Lymphocytic Leukemia (CLL), which affects the blood and bone marrow. The study is investigating the use of a treatment called Panzyga, which is a solution containing human normal immunoglobulin. This treatment is being compared to a placebo to see if it can help prevent infections in patients with CLL who have a weakened immune system, a condition known as secondary immunodeficiency. The goal is to determine if Panzyga can effectively reduce the risk of infections in these patients.

During the study, participants will receive either Panzyga or a placebo through an intravenous infusion, which means the solution is given directly into a vein. The study is designed to be double-blind, meaning neither the patients nor the doctors will know who is receiving the actual treatment or the placebo. This helps ensure that the results are unbiased. The study will last for a period of time, during which the safety and effectiveness of Panzyga in preventing infections will be closely monitored.

The main purpose of this study is to demonstrate the benefit of using Panzyga as a primary infection prevention method in patients with CLL who are undergoing treatment for their cancer. By comparing the occurrence of infections in patients receiving Panzyga versus those receiving a placebo, researchers hope to gather important information about the potential advantages of this treatment in managing the risk of infections in CLL patients with a compromised immune system.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, the patient is required to provide written and signed consent. This consent confirms understanding and agreement to participate in the study.

    Eligibility is confirmed based on specific criteria, including a diagnosis of chronic lymphocytic leukemia (CLL) and low levels of immunoglobulin G (IgG).

  2. Step 2

    Treatment allocation

    The study is double-blind, meaning neither the patient nor the doctor knows whether the patient receives the active treatment or a placebo.

    Patients are randomly assigned to receive either the active treatment, Panzyga, or a placebo.

  3. Step 3

    Medication administration

    The active treatment, Panzyga, is administered as an intravenous infusion. This means the medication is given directly into a vein through a needle.

    The specific dosage and frequency of administration are determined by the study protocol and are monitored by the healthcare team.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, the patient is monitored for any signs of infection and other health changes.

    Regular follow-up visits are scheduled to assess the patient's health and the effectiveness of the treatment.

  5. Step 5

    Study completion

    The study is expected to conclude by March 2025.

    Upon completion, the patient's health and any outcomes related to infection prevention are evaluated.

Who can join the trial?

5 criteria

  • Patients must have **chronic lymphocytic leukemia (CLL)**, which is a type of cancer that affects a group of white blood cells called lymphocytes.
  • Patients can be either new to treatment or have had previous treatments that did not work or stopped working. They must be currently receiving treatment for CLL.
  • Patients must have **hypogammaglobulinemia**, which means they have low levels of a type of protein called immunoglobulin G (IgG) in their blood. This must be confirmed by a laboratory test showing IgG levels less than 5 grams per liter.
  • Patients must be **18 years of age or older**.
  • Patients must provide written consent, meaning they agree to participate in the study after being fully informed about it.

Who cannot join the trial?

10 criteria

  • Patients who have a known allergy or severe reaction to the study medication or its ingredients.
  • Patients with a history of severe allergic reactions to blood products.
  • Patients who are currently participating in another clinical trial.
  • Patients with a serious medical condition that might interfere with the study, such as uncontrolled heart disease or severe liver problems.
  • Patients who are pregnant or breastfeeding.
  • Patients with an active infection that requires treatment with antibiotics.
  • Patients who have received another investigational drug within the last 30 days.
  • Patients with a history of drug or alcohol abuse that might affect their ability to follow the study procedures.
  • Patients who have had a recent vaccination with a live vaccine.
  • Patients with a condition that affects their immune system, other than the one being studied.
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Investigated drugs

Panzyga is a medication used in this clinical trial to help prevent infections in patients with chronic lymphocytic leukemia (CLL) who have a weakened immune system due to their cancer treatment. It is an immunoglobulin therapy, which means it contains antibodies that can help boost the immune system and protect against infections. The study aims to show how effective and safe Panzyga is in reducing the risk of infections in these patients.

What is already known about the treatment

Panzyga – Panzyga is administered intravenously, meaning it is given directly into a vein. It is currently being studied in a Phase III clinical trial to assess its effectiveness and safety for preventing infections in patients with chronic lymphocytic leukemia (CLL) who have secondary immunodeficiency. The main therapeutic use of Panzyga in this context is to prevent primary infections in these patients. At the molecular level, Panzyga works by providing immunoglobulins, which are antibodies that help the immune system fight infections. It is classified pharmacologically as an immunoglobulin therapy.

Investigated diseases

Chronic Lymphocytic Leukemia (CLL) – Chronic Lymphocytic Leukemia is a type of cancer that affects the blood and bone marrow. It is characterized by the production of an excessive number of abnormal white blood cells called lymphocytes. These abnormal cells accumulate over time, crowding out healthy blood cells and impairing the immune system. CLL progresses slowly and may not cause symptoms for years. As the disease advances, it can lead to symptoms such as fatigue, swollen lymph nodes, and frequent infections. The progression of CLL varies among individuals, with some experiencing a more aggressive form of the disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509737-39-00Protocol codeNGAM-12Estimated enrolment240 patientsSponsorOctapharma Pharmazeutika Produktionsgesellschaft mbH

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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