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Study of Axi-Cel, Fludarabine Phosphate, and Cyclophosphamide for Patients with Relapsed/Refractory Aggressive B-Cell Non-Hodgkin Lymphoma Ineligible for Stem Cell Transplant

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 clinical trial is focused on studying a type of cancer called Relapsed/Refractory aggressive B-cell non-Hodgkin lymphoma (B-NHL). This is a condition where the cancer has either returned after treatment or has not responded to initial treatments. The study is evaluating a treatment called Axicabtagene Ciloleucel, also known as Axi-Cel, which is a form of cell therapy. This treatment involves modifying a patient's own immune cells to better fight the cancer. The study also involves the use of other medications, Fludarabine Phosphate and Cyclophosphamide, which are used to prepare the body for the main treatment.

The purpose of the study is to assess how well Axi-Cel works as a second-line therapy for patients who cannot undergo a procedure called autologous stem cell transplantation. This is a treatment option that uses a patient's own stem cells to help recover from high-dose chemotherapy. The study will monitor the patients' response to the treatment over a period of time, specifically looking at the complete metabolic response, which is a measure of how much the cancer has decreased or disappeared, at three months after receiving Axi-Cel.

Participants in the study will receive the treatment through an infusion, which is a method of delivering medication directly into the bloodstream. The study will track the progress of the participants at various intervals to see how the treatment affects their cancer and overall health. The goal is to gather information on the effectiveness and safety of Axi-Cel in treating this type of lymphoma. The study is expected to continue until 2025, providing valuable insights into this promising treatment option.

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

    Leukapheresis procedure

    The process begins with a procedure called leukapheresis. This involves collecting white blood cells from the blood. It is necessary to have adequate vascular access, which means having a suitable vein for the procedure.

    This step is crucial for preparing the cells that will be modified and used later in the treatment.

  2. Step 2

    Pre-treatment with fludarabine phosphate and cyclophosphamide

    Before receiving the main treatment, two medications are administered: fludarabine phosphate and cyclophosphamide. These are given through an infusion.

    The purpose of these medications is to prepare the body for the main treatment by reducing the number of existing immune cells.

  3. Step 3

    Axicabtagene ciloleucel infusion

    The main treatment involves an infusion of axicabtagene ciloleucel. This is a type of therapy that uses modified cells to target and fight the lymphoma.

    The goal is to achieve a complete metabolic response, which means the disease shows no signs of activity on a PET scan.

  4. Step 4

    Monitoring and follow-up

    After the infusion, regular monitoring is conducted to assess the response to the treatment. This includes imaging tests like PET scans to evaluate the disease status.

    The primary objective is to achieve a complete metabolic response at 3 months post-infusion. Additional assessments are made at 6 and 12 months to evaluate event-free survival and other outcomes.

  5. Step 5

    Long-term follow-up

    Long-term follow-up is essential to monitor the duration of response, progression-free survival, and overall survival.

    The safety of the treatment and its impact on quality of life are also evaluated over a period of up to 3 years.

Who can join the trial?

24 criteria

  • Sign a written consent form to participate in the study.
  • Be eligible for **CAR T-cells therapy**, which is a treatment that uses the patient's own immune cells to fight cancer. This includes:
    • Approval by a doctor specializing in CAR-T therapy.
    • **ECOG performance status** of 0, 1, or 2, which measures how well a patient can perform daily activities.
    • Have suitable veins for a procedure called **leukapheresis**, which collects white blood cells.
    • Have a certain level of **neutrophils**, a type of white blood cell, in the blood.
    • Have a certain level of **platelets**, which help with blood clotting.
    • Have a certain level of **lymphocytes**, another type of white blood cell.
    • Have a **creatinine clearance** of at least 40 mL/min, which measures kidney function.
    • Have liver enzymes (ALT/AST) within a specific range.
    • Have a certain level of **bilirubin**, a substance made by the liver, unless they have a condition called **Gilbert's syndrome**.
    • Have a **cardiac ejection fraction** of at least 45%, which measures heart function.
    • Have an oxygen level of at least 92% when breathing room air.
    • Women who can have children must have a negative pregnancy test, unless they are unable to have children due to surgery or menopause.
    • Understand and speak one of the official languages of the country where the study is conducted.
    • Have a confirmed diagnosis of **relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (B-NHL)**, which is a type of cancer that has returned or not responded to treatment. This includes specific types like **diffuse large B-cell lymphoma (DLBCL)** and others.
    • Have tumor tissue available for review and additional studies.
    • Have a **PET-positive disease**, meaning the cancer shows up on a specific type of scan.
    • Have received adequate first-line therapy, including:
      • An **anti-CD20 monoclonal antibody**, which is a type of drug that targets cancer cells.
      • **CHOP or CHOP-like chemotherapy**, which are specific combinations of cancer drugs.
      • Have relapsed or refractory disease after first-line chemoimmunotherapy, documented by a PET scan. This means:
        • Relapsed disease: Cancer returned within 12 months after initial treatment.
        • Refractory disease: Cancer did not respond well to initial treatment.
        • At least 2 weeks must have passed since any previous cancer treatment before joining the study.
        • Be ineligible for **autologous stem cell transplantation (ASCT)**, which is a procedure that uses the patient's own stem cells to treat cancer. This includes:
          • Being deemed ineligible for high-dose chemotherapy and ASCT by a doctor.
          • Being 65 years or older, or 18 years or older with certain health conditions or having had a previous ASCT.

Who cannot join the trial?

10 criteria

  • Patients who have received other cancer treatments recently.
  • Patients with other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent infection that requires treatment.
  • Patients with a history of another type of cancer, unless it has been treated and is in remission.
  • Patients who have had an organ transplant.
  • Patients with certain heart conditions.
  • Patients who are unable to follow the study procedures.
  • Patients who have allergies to the study medication or its ingredients.
  • Patients who are participating in another clinical trial.
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Investigated drugs

Axi-cel is a type of therapy used in the clinical trial. It is a form of treatment that involves modifying a patient's own immune cells to better recognize and attack cancer cells. This therapy is specifically designed to target and destroy cancer cells in the body, and the trial aims to evaluate its effectiveness in achieving a complete metabolic response, meaning the cancer is no longer detectable, three months after the infusion.

What is already known about the treatment

Axi-cel – Axi-cel is administered as an intravenous infusion, typically in a clinical setting under the supervision of healthcare professionals. It is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (B-NHL). The medication works by modifying a patient's own T-cells to better recognize and attack cancer cells, enhancing the immune system's ability to fight the disease. Axi-cel is classified as a type of CAR T-cell therapy, which is a form of immunotherapy designed to target specific cancer cells.

Investigated diseases

Relapsed/Refractory Aggressive B-Cell Non-Hodgkin Lymphoma – This is a type of cancer that originates in the lymphatic system, specifically affecting B-cells, which are a type of white blood cell. It is characterized by the rapid growth of malignant cells that form tumors in the lymph nodes and other parts of the body. The term "relapsed" refers to the return of the disease after treatment, while "refractory" indicates that the disease does not respond to standard treatments. As the disease progresses, it can spread to other organs and tissues, leading to a variety of symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The aggressive nature of this lymphoma means it grows and spreads quickly, requiring prompt medical attention.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-513659-34-00Protocol codeALYCANTEEstimated enrolment42 patientsSponsorLysarc

sourced from the EU Clinical Trials Register and site verification

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