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Study Comparing Tisagenlecleucel with Standard Treatment for Adults with Relapsed or Refractory Follicular 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 follicular lymphoma, which is a form of non-Hodgkin lymphoma affecting the lymphatic system. The trial is specifically for adult patients whose disease has returned or has not responded to at least two previous treatments. The main treatment being tested in this study is called tisagenlecleucel, also known by its code name CTL019. This is a type of cell therapy that uses the patient's own immune cells, which are modified to better fight cancer. The study will compare the effectiveness of tisagenlecleucel with the standard treatments currently used for this condition.

Participants in the study will receive either tisagenlecleucel or one of the standard treatments, which may include medications like rituximab, cyclophosphamide monohydrate, doxorubicin hydrochloride, vincristine sulfate, prednisone, prednisolone, fludarabine phosphate, lenalidomide, bendamustine hydrochloride, or tocilizumab. Some participants may receive a placebo. The purpose of the study is to determine if tisagenlecleucel can improve the time patients live without their disease getting worse, which is known as progression-free survival.

The study will involve regular visits to the clinic for treatment and monitoring. Participants will undergo various tests and assessments to track their health and the progress of their disease. The trial will last for several years, with the aim of gathering comprehensive data on the safety and effectiveness of tisagenlecleucel compared to standard treatments. This information will help determine the best treatment options for patients with relapsed or refractory follicular lymphoma.

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

    Enrollment and initial assessment

    Upon joining the clinical trial, you will undergo an initial assessment to confirm eligibility. This includes a review of your medical history and a series of tests to ensure you meet the trial's criteria.

    You will be asked to sign an informed consent form, which explains the trial's purpose, procedures, and potential risks and benefits.

  2. Step 2

    Randomization

    After the initial assessment, you will be randomly assigned to one of two groups: the tisagenlecleucel treatment group or the standard of care group. This process is random to ensure unbiased results.

  3. Step 3

    Treatment phase

    If assigned to the tisagenlecleucel group, you will receive this treatment through an intravenous infusion. The schedule and dosage will be determined by the study team based on your specific needs.

    If assigned to the standard of care group, you will receive medications such as fludarabine phosphate, cyclophosphamide monohydrate, rituximab, and others as per the standard treatment protocol. These may be administered intravenously or orally, depending on the specific medication.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, regular monitoring will be conducted to assess your response to the treatment. This includes physical exams, blood tests, and imaging studies like CT or PET scans.

    You will be required to attend follow-up visits as scheduled by the study team to ensure your safety and to monitor the effectiveness of the treatment.

  5. Step 5

    Completion and final assessment

    At the end of the treatment phase, a final assessment will be conducted to evaluate the overall response to the treatment. This will include a comprehensive review of your health status and any changes observed during the trial.

    You will receive information about the next steps and any additional follow-up that may be necessary after the trial concludes.

Who can join the trial?

8 criteria

  • Must be at least 18 years old at the time of signing the consent form.
  • Must have follicular lymphoma grade 1, 2, or 3A confirmed by a test after the latest relapse.
  • Must have a disease that has come back or did not respond after at least two different treatments, including a treatment with an anti-CD20 antibody and an alkylating agent (types of cancer treatments).
  • The disease must be active on a PET scan (a type of imaging test) and measurable on a CT scan (another type of imaging test).
  • Must have an ECOG performance status of 0, 1, or 2 at screening. This is a scale that measures how well a person can perform daily activities, where 0 means fully active and 2 means unable to work but able to do all self-care.
  • Must have adequate function of blood, kidneys, liver, and lungs at screening.
  • Must meet the criteria to undergo leukapheresis (a procedure to collect white blood cells) unless this has been done before.
  • Must be eligible for treatment with the chosen standard care regimen.

Who cannot join the trial?

4 criteria

  • Patients who have not received at least two prior lines of systemic therapy for their condition.
  • Patients with medical conditions other than **follicular B-cell non-Hodgkin lymphoma** grade 1-3A that is **relapsed** (came back after treatment) or **refractory** (did not respond to treatment).
  • Patients who are not adults.
  • Patients who are part of a vulnerable population that requires special protection.
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Investigated drugs

Tisagenlecleucel is a type of treatment known as CAR-T cell therapy. It involves taking some of your own immune cells, called T cells, and modifying them in a laboratory to better recognize and attack cancer cells. Once these modified cells are ready, they are infused back into your body to help fight the cancer. This therapy is specifically used for certain types of blood cancers, like follicular lymphoma, when other treatments have not worked.

What is already known about the treatment

Tisagenlecleucel – Tisagenlecleucel is administered as an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating adult patients with a type of cancer called follicular B-cell non-Hodgkin lymphoma, specifically in cases where the disease has returned or not responded to at least two previous treatments. This medication works by modifying the 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

Follicular B-cell non-Hodgkin lymphoma – This is a type of blood cancer that affects B-lymphocytes, a kind of white blood cell. It typically progresses slowly and is characterized by the formation of tumors in the lymph nodes. Over time, the disease can spread to other parts of the body, including the bone marrow and spleen. Patients may experience symptoms such as swollen lymph nodes, fatigue, and night sweats. The disease often goes through periods of remission and relapse. As it advances, it may transform into a more aggressive form of lymphoma.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503452-27-00Protocol codeCCTL019E2301Estimated enrolment108 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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