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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Cbjifh Hlqinewligy Eh Undmejchwatfr Dn Ljtxeac Limoges France
Csdeyn Hfxbwdosblx Rapdahaq Unxneyhylbkud Dj Tgsty Tours France
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Iapqukfn da Cnkzkepqztki Hjbnzntkneg Uonxwobjrkoha dx Sthqm Ehsuqtg (tqvehom Saint Priest En Jarez France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
02.03.2026

Trial locations

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.

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 ID:
2025-521571-30-00
Protocol code:
APHP241013
Trial Phase:
Therapeutic confirmatory (Phase III)

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