Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

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

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511594-30-00Protocol codeKT-US-473-0133Estimated enrolment217 patientsSponsorKite Pharma Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.