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Comparing human normal immunoglobulin (iv) and a drug combination to prevent infections in adults with B-cell acute lymphoblastic leukemia or B-cell lymphoma treated with CAR-T cells

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study focuses on individuals treated with CAR-T cells, a type of immunotherapy used to fight certain cancers. Specifically, the research involves patients with B-cell acute lymphoblastic leukemia, a type of blood cancer, or B-cell lymphoma, a cancer of the immune system. Following this treatment, patients may be at a higher risk for infections. The purpose of the study is to compare two different ways to prevent these infections.

One method being studied is immunoglobulin replacement therapy, which involves the administration of human normal immunoglobulin through an intravenous line, meaning it is delivered directly into a vein. The other method is antibiotic prophylaxis, which is the use of medications to prevent infections before they occur. The medications used for comparison in this study include amoxicillin trihydrate, sulfamethoxazole, trimethoprim, bromhexine hydrochloride, levofloxacin, amoxicillin sodium, and azithromycin.

Participants in the study will be assigned to one of the two prevention methods. During the follow-up period, which lasts for 12 months, the occurrence of infections will be monitored. This includes looking for recurrent infections that require treatment or severe infections that lead to a hospital stay.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>treatment assignment</b>

    After joining the study, one of two different preventive treatment methods will be assigned. one method is immunoglobulin replacement therapy, which uses human normal immunoglobulin given through a vein at a dose of 400 mg/kg (milligrams per kilogram of body weight). the other method is antibiotic prophylaxis, which involves taking antibiotics (medicines used to prevent or treat bacterial infections) to prevent infections from occurring.

  2. Step 2

    <b>preventive medication administration</b>

    If assigned to the antibiotic prophylaxis group, one of the following oral medications (taken by mouth) will be used according to specific center guidelines: amoxicillin trihydrate at 1000 mg, sulfamethoxazole and trimethoprim at 800 mg, levofloxacin at 500 mg, amoxicillin sodium at 1000 mg, or azithromycin at 250 mg.

  3. Step 3

    <b>monitoring and follow-up</b>

    Over the course of 12 months following the start of treatment, various measurements will be taken. these include blood tests to count lymphocytes (a type of white blood cell that helps the body fight infection) and levels of antibodies (proteins that help the immune system recognize and fight germs) at months 1, 3, 6, 9, and 12.

    The quality of life will also be assessed through specific questionnaires during this period.

Who can join the trial?

6 criteria

  • You must be between 16 and 80 years old at the start of the study.
  • You must have B-cell acute lymphoblastic leukemia (a type of blood cancer) or B-cell lymphoma (a type of cancer that starts in the lymph nodes, such as diffuse large B cell lymphoma, mantle cell lymphoma, or follicular lymphoma).
  • You must have low levels of gammaglobulins, which are antibodies (proteins in the blood that help fight infections), measured at less than 4g/L during the lymphodepletion phase (the process of using medicine to reduce the number of certain white blood cells before treatment).
  • You must be receiving CD19-targeted autologous CAR-T cells (a type of immune system therapy where your own modified cells are used to fight cancer).
  • People who are able to become pregnant must use reliable contraception (methods to prevent pregnancy) throughout the entire study and for another 12 months after receiving the cell therapy.
  • You or your legal representative must provide informed consent, which means signing a document that explains the study details and your agreement to participate.

Who cannot join the trial?

8 criteria

  • A history of being unable to tolerate intravenous immunoglobulin, which is a treatment where proteins used to help the immune system are delivered directly into a vein.
  • Having renal failure, which means the kidneys are not working properly, specifically if the glomerular filtrate rate (a measure of how well the kidneys filter blood) is less than 30 mL per minute.
  • Having hepatic failure, which is severe liver damage, or hepatitis, which is inflammation of the liver, or having high levels of bilirubin (a yellow substance in the blood) or liver enzymes like ALT and AST that are much higher than normal.
  • Having a current serious acute infection, which is a sudden and severe illness caused by germs.
  • Having any medical reason why you cannot receive immunoglobulin or prophylactic antibiotherapy, which refers to taking antibiotics to prevent an infection before it happens.
  • Not having health insurance coverage.
  • Being a female who is pregnant or breastfeeding.
  • Currently taking part in another interventional study (a clinical trial where a treatment is given) or being in the waiting period required after finishing a previous study.
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Investigated drugs

  • Normal human immunoglobulin

    is the therapy being tested in this study. It is given through a vein to help strengthen the immune system and prevent infections in patients who may have a weakened immune response following their specialized cancer treatment.

  • Amoxicillin

    is an antibiotic used in this study as a comparison treatment to help prevent bacterial infections.

  • Sulfamethoxazole and trimethoprim

    is a combination antibiotic used in this study as a comparison treatment to help prevent bacterial infections.

  • Levofloxacin

    is an antibiotic used in this study as a comparison treatment to help prevent bacterial infections.

  • Azithromycin

    is an antibiotic used in this study as a comparison treatment to help prevent bacterial infections.

What is already known about the treatment

  • Amoxicillin trihydrate

    This antibiotic is taken by mouth to treat various bacterial infections. It is a widely used medication that works by preventing bacteria from building their protective cell walls, which eventually leads to their death. This drug belongs to the penicillin group of antibiotics and is a standard treatment in modern medicine.

  • Sulfamethoxazole and trimethoprim

    These two drugs are taken orally as a combination to fight different types of bacterial infections. They work together by blocking two different steps in the bacteria's ability to create essential nutrients, effectively starving the germs. This combination is a well-established antibiotic treatment used frequently in clinical practice.

  • Levofloxacin

    This medication is administered orally to treat a wide range of bacterial infections. It works at a molecular level by interfering with the enzymes that bacteria need to repair and copy their DNA, preventing them from multiplying. It belongs to a class of antibiotics known as fluoroquinolones and is commonly used in various medical settings.

  • Amoxicillin sodium

    This antibiotic is taken by mouth to treat various infections caused by bacteria. It functions by attacking the structure of the bacterial cell wall, making it impossible for the bacteria to survive. As part of the penicillin family, it is one of the most commonly prescribed antibiotics in the world.

  • Azithromycin

    This antibiotic is administered orally to treat many types of bacterial infections. It works by stopping bacteria from producing the proteins they need to grow and function. Classified as a macrolide antibiotic, it is a widely recognized and used medication in clinical medicine.

  • Human normal immunoglobulin

    This treatment is administered through an intravenous infusion to help support the immune system. It consists of antibodies collected from healthy donors that help the body recognize and fight off harmful germs. This therapy is used to replace missing or low levels of antibodies in patients with weakened immune systems.

Investigated diseases

B-cell acute lymphoblastic leukemia - This is a type of cancer that affects the white blood cells known as B cells. It begins in the bone marrow, where abnormal cells grow rapidly and crowd out healthy blood cells. As the disease progresses, the body struggles to produce enough normal blood cells to function correctly. B-cell lymphoma - This is a cancer that develops in the lymphatic system, which is part of the body's immune system. It occurs when B cells, a type of white blood cell, undergo uncontrolled growth within the lymph nodes or other organs. The disease can spread through the lymphatic system to different parts of the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521571-30-00Protocol codeAPHP241013Estimated enrolment228 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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