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Study Comparing Axicabtagene Ciloleucel and Standard Treatment for Adults with High-Risk Large B-Cell Lymphoma

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 high-risk large B-cell lymphoma, which includes subtypes like diffuse large B-cell lymphoma and high-grade B-cell lymphoma. The trial aims to compare the effectiveness of a new treatment called axicabtagene ciloleucel with the standard treatments currently used for this condition. Axicabtagene ciloleucel is a type of therapy that involves modifying a patient's own immune cells to better fight cancer.

Participants in the study will receive either axicabtagene ciloleucel or standard treatments, which may include medications such as prednisone, cyclophosphamide, dexamethasone, vincristine, tocilizumab, doxorubicin, diphenhydramine, rituximab, etoposide, mesna, methylprednisolone, fludarabine, and other analgesics and antipyretics. Some participants may receive a placebo. The study will monitor how well the treatments work by looking at how long participants live without the cancer getting worse and other health outcomes.

The trial will take place over a period of time, during which participants will receive their assigned treatment and have regular check-ups to monitor their health and the progress of the treatment. The goal is to determine which treatment is more effective in improving the lives of people with high-risk large B-cell lymphoma. Participants will be closely monitored for any side effects or changes in their condition throughout the study.

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, you will be randomly assigned to one of two groups. One group will receive the new treatment called axicabtagene ciloleucel, and the other group will receive the standard treatment for high-risk large B-cell lymphoma.

  2. Step 2

    Treatment preparation

    If you are assigned to the axicabtagene ciloleucel group, you will undergo a process called leukapheresis. This involves collecting your white blood cells, which will be modified and used to create the treatment.

    You may receive medications such as fludarabine and cyclophosphamide through an intravenous infusion to prepare your body for the treatment. These medications help to create a suitable environment for the modified cells to work effectively.

  3. Step 3

    Receiving the treatment

    The axicabtagene ciloleucel treatment is given as a single intravenous infusion. This means the modified cells are delivered directly into your bloodstream through a vein.

    If you are in the standard treatment group, you will receive the usual medications for your condition, which may include drugs like rituximab, etoposide, and prednisone. These are also administered through intravenous infusion or orally, depending on the specific medication.

  4. Step 4

    Monitoring and follow-up

    After receiving the treatment, you will be closely monitored for any side effects or changes in your condition. This includes regular check-ups and tests to assess your response to the treatment.

    You may be asked to complete questionnaires about your quality of life and any symptoms you experience. This information helps to evaluate the impact of the treatment on your daily life.

  5. Step 5

    Long-term follow-up

    The study will continue to follow your progress for several years to gather information on the long-term effects and benefits of the treatment.

    Regular visits and assessments will be scheduled to monitor your health and any ongoing effects of the treatment.

Who can join the trial?

11 criteria

  • Must be an adult aged 18 years or older.
  • Must have a type of lymphoma called large B-cell lymphoma (LBCL), which includes diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL).
  • Must have a high-risk disease with an IPI score of 4 or 5 at the initial diagnosis. (IPI stands for International Prognostic Index, which helps to assess the risk level of lymphoma.)
  • Must have Ann Arbor Stage III or IV disease, which indicates advanced stages of lymphoma.
  • Must have received only one cycle of a specific type of chemotherapy called R-chemotherapy.
  • Must have at least one measurable tumor based on a CT scan, with specific size requirements for lymph nodes and other lesions.
  • Must have a tumor sample available for review by a central pathology lab.
  • Females of childbearing potential must have a negative pregnancy test. (Females who have had surgical sterilization or have been postmenopausal for at least 2 years are not considered to be of childbearing potential.)
  • Must have an ECOG performance status of 0-2 at the time of randomization. (ECOG is a scale used to assess how a disease affects a patient's daily living abilities.)
  • Must have adequate function of bone marrow, kidneys, liver, lungs, and heart, as indicated by specific medical tests and criteria.
  • Must have a baseline oxygen level greater than 92% on room air.

Who cannot join the trial?

11 criteria

  • Patients who have had another type of cancer in the past, except for certain skin cancers or cervical cancer that has been treated.
  • Patients who have an active infection that needs treatment.
  • Patients who have a history of severe allergic reactions to certain medications.
  • Patients who have a serious heart condition.
  • Patients who have a serious lung condition.
  • Patients who have a serious liver condition.
  • Patients who have a serious kidney condition.
  • Patients who are pregnant or breastfeeding.
  • Patients who have received certain treatments for their lymphoma in the past.
  • Patients who have a condition that affects their immune system.
  • Patients who are participating in another clinical trial.
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Investigated drugs

Axicabtagene Ciloleucel is a type of therapy that uses your own immune cells to fight cancer. In this treatment, some of your white blood cells, which are part of your immune system, are taken out of your body. These cells are then changed in a lab to help them recognize and attack cancer cells more effectively. After this process, the modified cells are put back into your body to help fight the lymphoma. This therapy is being tested to see if it works better than the usual treatments for people with a type of cancer called high-risk large B-cell lymphoma.

What is already known about the treatment

Axicabtagene Ciloleucel – Axicabtagene ciloleucel is administered as an infusion directly into the bloodstream, a method known as intravenous administration. It is currently being studied in clinical trials as a first-line treatment for adults with high-risk large B-cell lymphoma, including diffuse large B-cell lymphoma and high-grade B-cell lymphoma. This medication works by modifying a patient's own immune cells to better recognize and attack cancer cells. It belongs to a class of treatments known as CAR T-cell therapies, which are designed to enhance the body's natural defenses against cancer.

Investigated diseases

  • Diffuse Large B-Cell Lymphoma, Not Otherwise Specified (DLBCL, NOS)

    This is a type of non-Hodgkin lymphoma characterized by the rapid growth of large B-cells in the lymphatic system. It typically begins in the lymph nodes but can also affect other organs. The disease progresses quickly, with symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. As it advances, it can spread to other parts of the body, including the bone marrow and central nervous system. The progression involves the uncontrolled proliferation of abnormal B-cells, which can disrupt normal immune function.

  • High-Grade B-Cell Lymphoma (HGBL)

    This is an aggressive form of non-Hodgkin lymphoma that involves rapidly growing B-cells. It often presents with symptoms like enlarged lymph nodes, fever, and fatigue. The disease progresses swiftly, with the potential to spread beyond the lymphatic system to other organs. It is characterized by a high proliferation rate of malignant cells, leading to a quick deterioration of the patient's condition. The rapid growth of these cells can cause significant disruption to normal bodily functions.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501489-24-00Protocol codeKT-US-484-0136Estimated enrolment294 patientsSponsorKite Pharma Inc.

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