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Study Comparing Axicabtagene Ciloleucel with Standard Treatment for Patients with Relapsed or Refractory Follicular Lymphoma

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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 Follicular Lymphoma. This is a condition where the cancer has returned or is not responding to treatment. The study is comparing a new treatment called axicabtagene ciloleucel with the standard treatments that are currently used for this type of lymphoma. Axicabtagene ciloleucel is a type of cell therapy, which means it uses specially modified cells to help fight the cancer. The standard treatments being compared include medications like Vincristine Sulfate, Cyclophosphamide, Doxorubicin Hydrochloride, Lenalidomide, Prednisolone, Rituximab, and Bendamustine Hydrochloride.

The purpose of the study is to see if axicabtagene ciloleucel is more effective than the standard treatments in helping patients live longer without the cancer getting worse. Participants in the study will receive either the new treatment or one of the standard treatments. The study will monitor the progress of the disease and any side effects that may occur. The treatment will be given through an infusion, which means it is delivered directly into the bloodstream through a vein.

Throughout the study, participants will have regular check-ups to assess their health and the effectiveness of the treatment. The study aims to provide valuable information on whether axicabtagene ciloleucel can offer a better outcome for patients with relapsed or refractory follicular lymphoma compared to the current standard treatments. This research is important for developing new and improved ways to treat this type of cancer.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of relapsed/refractory follicular lymphoma and ensuring adequate organ function.

    The assessment involves a review of medical history and a physical examination to identify measurable lesions.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either axicabtagene ciloleucel or standard of care therapy. This process is essential to compare the effectiveness of the treatments.

  3. Step 3

    Treatment administration

    For those receiving axicabtagene ciloleucel, the treatment is administered as a dispersion for infusion through an intravenous route.

    Participants receiving standard of care therapy may be given a combination of medications, including vincristine sulfate, cyclophosphamide, doxorubicin hydrochloride, lenalidomide, prednisolone, rituximab, and bendamustine hydrochloride. These are administered either intravenously or orally, depending on the specific medication.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment and any side effects. This includes imaging studies and laboratory tests.

    Participants are evaluated for progression-free survival, overall survival, and other health outcomes as part of the study's objectives.

  5. Step 5

    End of study participation

    The study is estimated to conclude by October 31, 2030. Participants will be informed about the end of their involvement and any necessary follow-up care.

Who can join the trial?

6 criteria

  • The patient must have a type of cancer called follicular lymphoma, confirmed by a test. This can be Grade 1, 2, or 3a.
  • The patient must have a condition called relapsed/refractory disease, which means the cancer has come back or is not responding to treatment. This should happen after the first round of treatment and within 24 months, or after at least two previous treatments.
  • The patient must need treatment based on their current health condition.
  • The patient must have at least one tumor that can be measured using a specific method called the Lugano Classification.
  • The patient must have good enough kidney, liver, lung, and heart function to participate in the study.
  • Both male and female patients can participate.

Who cannot join the trial?

11 criteria

  • Patients who have another type of cancer that is not under control.
  • Patients who have an active infection that is not being treated.
  • Patients who have a serious heart condition that is not stable.
  • Patients who have a serious lung condition that is not stable.
  • Patients who have a serious liver condition that is not stable.
  • Patients who have a serious kidney condition that is not stable.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had another cancer treatment within a certain time frame before the study.
  • Patients who have had a major surgery within a certain time frame before the study.
  • Patients who have a history of certain mental health conditions that are not stable.
  • Patients who are unable to follow the study procedures for any reason.
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Investigated drugs

Axicabtagene Ciloleucel is a type of therapy known as CAR T-cell therapy. It involves modifying a patient's own immune cells to better recognize and attack cancer cells. This treatment is being tested to see if it is more effective than the usual treatments for patients with a type of blood cancer called follicular lymphoma that has returned or not responded to previous treatments.

What is already known about the treatment

Axicabtagene Ciloleucel – This medication is administered through an intravenous infusion. It is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory follicular lymphoma. The main therapeutic indication is for patients whose follicular lymphoma has returned or not responded to previous treatments. At the molecular level, axicabtagene ciloleucel works by modifying a patient's own T-cells to better recognize and attack cancer cells. It is classified as a type of CAR T-cell therapy, which is a form of immunotherapy.

Investigated diseases

Relapsed/Refractory Follicular Lymphoma – This is a type of non-Hodgkin lymphoma that originates in the lymphatic system and is characterized by the abnormal growth of B-lymphocytes. It is termed "relapsed" when the disease returns after treatment and "refractory" when it does not respond to standard treatments. The disease typically progresses slowly, but over time, it can become more aggressive. Patients may experience symptoms such as swollen lymph nodes, fatigue, and night sweats. As the disease advances, it can affect other organs and lead to more severe health issues.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511594-30-00Protocol codeKT-US-473-0133Estimated enrolment217 patientsSponsorKite Pharma Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).