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Study of fludarabine phosphate in patients with blood cancer undergoing lymphodepletion before CAR-T cell therapy

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 is being conducted to evaluate how the body processes a specific medication during a certain type of preparation for advanced cancer treatment. The research focuses on patients with a hematological malignancy, which is a type of cancer that affects the blood or bone marrow, who are preparing for CAR-T cell therapy. This advanced treatment involves using specially modified immune cells to fight cancer. Before receiving these modified cells, patients undergo lymphodepletion, a process using medications to reduce the number of certain white blood cells to make the treatment more effective.

The treatment being studied involves the use of fludarabine phosphate, which is administered through an intravenous line, meaning it is delivered directly into a vein. This medication is used alongside cyclophosphamide as part of the preparation process. The study also takes into account patients who have previously received or are scheduled to receive other specialized cell therapies, such as tisagenlecleucel, axicabtagene ciloleucel, brexucabtagene autoleucel, or ciltacabtagene autoleucel. The goal is to understand the pharmacokinetics, or how the drug moves through, is absorbed by, and is eliminated from the body.

During the course of the study, blood samples will be collected to measure the levels of the medication in the blood over time. These measurements help determine the maximum observed concentration and the overall exposure to the drug. Researchers will also look at various patient factors, such as weight and kidney function, to see how they might relate to how the body handles the medication.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Lymphodepletion therapy

    The process begins with lymphodepletion, which is a treatment to reduce the number of white blood cells in the body to prepare for the next stage.

    During this stage, fludarabine is administered through an intravenous line, which means it is delivered directly into a vein. the dose is 30 mg/m2 (milligrams per square meter of body surface area).

    cyclophosphamide is also administered through an intravenous line. the dose is 900 mg/m2 (milligrams per square meter of body surface area).

  2. Step 2

    Car-t cell therapy

    Following the lymphodepletion stage, car-t cell therapy is administered via intravenous infusion.

    This stage involves receiving specialized cells, such as tisagenlecleucel, axicabtagene ciloleucel, brexucabtagene autoleucel, or ciltacabtagene autoleucel, depending on the specific treatment plan.

Who can join the trial?

8 criteria

  • You must be 18 years of age or older.
  • You must be able to understand and sign an informed consent form, which is a document that explains all the details of the study before you agree to join.
  • Women who are able to become pregnant must use a reliable form of contraception, such as hormonal methods or barrier methods, during their treatment and for up to 6 months after.
  • Men must use a barrier method of protection during their treatment and for up to 6 months after.
  • You must be receiving CAR T-cell therapy, which is a type of treatment where your own immune cells are changed in a lab to help fight cancer.
  • You must have a hematological malignancy, which is a type of cancer that affects the blood or the blood-forming tissues like bone marrow.
  • You must be scheduled to receive lymphodepletion, which is a type of chemotherapy used to reduce the number of certain white blood cells in your body to prepare it for the CAR T-cell therapy.
  • Your treatment plan must include a specific medicine called Fludarabine.

Who cannot join the trial?

8 criteria

  • You are pregnant or currently breastfeeding.
  • You have a known allergic reaction, which is an unhealthy immune response, to any part of the lymphodepletion treatment (medicine used to reduce certain white blood cells).
  • You do not have a way to have blood taken other than the tube used to give the medicine, unless you have a central catheter (a thin tube placed in a large vein) with extra openings for blood collection.
  • You are unable or do not want to have blood taken from your peripheral veins (the veins in your arms or hands).
  • You are undergoing dialysis, which is a medical process that cleans your blood when your kidneys cannot do it.
  • You have renal insufficiency, which means your kidneys are not working well enough, specifically if your creatinine clearance (a measure of how well your kidneys filter waste) is less than 30 ml/min.
  • You have a serious or uncontrolled medical condition or an active infection that makes it unsafe for you to participate in the study or receive the treatment.
  • You have hemolysis, which is the premature destruction of your red blood cells, caused by the medicine, or you have decompensated hemolytic anemia, which is a condition where your body cannot keep up with the loss of red blood cells.
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Investigated drugs

Fludarabine is a medication used in this study to prepare the patient's body before receiving cell therapy. It works by reducing the number of certain immune cells in the body, a process known as lymphodepletion, which helps the upcoming therapy work more effectively.

What is already known about the treatment

  • Tisagenlecleucel

    This medication is an advanced gene therapy administered as a dispersion through an intravenous infusion. It is currently an approved treatment used primarily for certain types of blood cancers like leukemia and lymphoma. The therapy works by genetically modifying a patient's own immune cells to recognize and attack cancer cells at a molecular level. It is classified as a chimeric antigen receptor (CAR) T-cell therapy.

  • Cyclophosphamide

    This medication is an anticancer drug provided as a solution for injection and is administered through an intravenous infusion. It is a well-established treatment used to manage various cancers and certain immune system disorders. The drug works by interfering with the DNA of rapidly dividing cells, which prevents them from multiplying and helps stop cancer growth. It belongs to a pharmacological class known as alkylating agents.

  • Fludarabine phosphate

    This medication is a chemotherapy drug delivered via intravenous injection or infusion. It is widely used in medical practice to treat various blood-related cancers and to prepare the body for other intensive therapies. At the molecular level, it interferes with the cell's ability to build and repair its genetic material, leading to the death of cancer cells. It is classified as a purine analog.

  • Axicabtagene ciloleucel

    This medication is a specialized gene therapy given as a dispersion through an intravenous infusion. It is an approved treatment specifically used for certain types of aggressive lymphoma. The substance works by reprogramming a patient's immune cells so they can specifically target and destroy cancer cells. This medication is classified as a chimeric antigen receptor (CAR) T-cell therapy.

  • Brexucabtagene autoleucel

    This medication is a cellular therapy administered as a dispersion through an intravenous infusion. It is currently used as a specialized treatment for specific types of blood cancers, such as mantle cell lymphoma. The therapy functions by modifying immune cells to recognize unique markers on the surface of cancer cells to trigger an immune response. It is classified as a chimeric antigen receptor (CAR) T-cell therapy.

  • Ciltacabtagene autoleucel

    This medication is an advanced biological therapy delivered as a dispersion through an intravenous infusion. It is an approved treatment used primarily for patients with certain types of multiple myeloma. The drug works by teaching the patient's own immune cells to identify and attack specific proteins found on the surface of cancer cells. It is classified as a chimeric antigen receptor (CAR) T-cell therapy.

Investigated diseases

Hematological malignancy - This refers to a group of cancers that begin in the blood-forming tissues, such as the bone marrow. These diseases affect the production and function of blood cells, including white blood cells, red blood cells, and platelets. The condition typically progresses as abnormal cells multiply uncontrollably, interfering with the normal production of healthy blood cells. This can lead to various imbalances in the blood components over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524278-40-00Protocol codeFLU-CARTEstimated enrolment75 patientsSponsorUniversitair Ziekenhuis Gent

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