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Study on the Effectiveness and Safety of Tisagenlecleucel for Adults with Hard-to-Treat or Returning 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 the effectiveness and safety of a treatment called tisagenlecleucel in adults with a type of cancer known as follicular lymphoma. Follicular lymphoma is a cancer that affects the lymphatic system, which is part of the body's immune system. The trial is specifically for patients whose disease has either not responded to previous treatments or has returned after treatment. The treatment being tested, tisagenlecleucel, is a type of cell therapy where a patient's own T cells, a kind of white blood cell, are modified to better fight cancer cells. This therapy is given through an intravenous infusion, which means it is delivered directly into the bloodstream.

The purpose of the study is to evaluate how well tisagenlecleucel works in treating follicular lymphoma and to assess its safety. Participants in the study will receive the treatment and will be monitored over time to see how their cancer responds. The study will also track any side effects or adverse events that occur during the treatment period. The trial is designed to gather information on the complete response rate, which is the percentage of patients whose cancer completely disappears after treatment, as well as other outcomes like overall response rate and progression-free survival, which measures how long patients live without their disease getting worse.

Throughout the study, participants will undergo regular check-ups and tests to monitor their health and the status of their lymphoma. These tests may include blood tests and imaging studies to see how the cancer is responding to the treatment. The study aims to provide valuable information on the potential benefits and risks of using tisagenlecleucel for treating follicular lymphoma, which could help improve future treatment options for this condition.

The research process

The trial runs in 7 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 a review of medical history and current health status.

    Eligibility criteria include being 18 years or older, having a confirmed diagnosis of follicular lymphoma, and meeting specific health and laboratory requirements.

  2. Step 2

    Leukapheresis procedure

    A leukapheresis procedure is performed to collect white blood cells. This is necessary for the manufacturing of the treatment product.

    The collected cells are non-mobilized, meaning they are taken directly from the bloodstream without prior stimulation.

  3. Step 3

    Manufacturing of tisagenlecleucel

    The collected cells are used to manufacture tisagenlecleucel, a personalized treatment. This process involves modifying the cells to help them target cancer cells more effectively.

    This step does not require any action from the patient and may take several weeks.

  4. Step 4

    Pre-infusion assessment

    Before receiving the treatment, another assessment is conducted to ensure the patient is ready for the infusion. This includes checking vital signs and overall health status.

  5. Step 5

    Tisagenlecleucel infusion

    The tisagenlecleucel is administered through an intravenous infusion. This is a one-time procedure where the modified cells are introduced into the bloodstream.

    The infusion is monitored closely to manage any immediate reactions.

  6. Step 6

    Post-infusion monitoring

    After the infusion, regular monitoring is conducted to assess the treatment's effectiveness and any side effects. This includes physical exams, blood tests, and imaging studies.

    Monitoring continues for a specified period to ensure the patient's safety and to evaluate the response to treatment.

  7. Step 7

    Follow-up assessments

    Follow-up assessments are scheduled periodically to track the patient's progress and any long-term effects of the treatment.

    These assessments help determine the overall success of the treatment and guide any further medical decisions.

Who can join the trial?

18 criteria

  • Provide written informed consent before any screening procedures.
  • Be at least 18 years old at the time of signing the consent form.
  • Have a type of cancer called **follicular lymphoma** (FL), confirmed by a special test before receiving the treatment.
  • Meet one of the following conditions related to follicular lymphoma:
    • The cancer did not respond to a second or later treatment, or it came back within 6 months after finishing a second or later treatment.
    • The cancer returned during or shortly after a specific maintenance treatment involving an anti-CD20 antibody, following at least two previous treatments.
    • The cancer came back after a procedure called **autologous HSCT**, which is a type of stem cell transplant using the patient's own cells.
    • Have a disease that can be measured by imaging tests, with at least one lymph node larger than 20 mm or other lesions larger than 10 mm.
    • Have a good general health status, as measured by a scale called **ECOG performance status**, with a score of 0 or 1.
    • Meet specific laboratory test values without needing a blood transfusion:
      • **Absolute neutrophil count** (ANC) of at least 1,000/mm3.
      • **Absolute lymphocyte count** (ALC) greater than 300/mm3.
      • **Absolute number of CD3+ T cells** greater than 150/mm3.
      • **Platelets** count of at least 50,000/mm3.
      • **Hemoglobin** level of at least 8.0 g/dl.
      • **Serum creatinine** level no more than 1.5 times the normal limit or an **eGFR** of at least 60 mL/min/1.73 m2.
      • **Liver enzymes** (ALT/AST) no more than 5 times the normal limit.
      • **Total bilirubin** no more than 1.5 times the normal limit, except for patients with **Gilbert’s syndrome**, who may have higher levels.
      • Have adequate lung function, with no or mild breathing difficulty and oxygen levels above 90% on room air.
      • Have a suitable **leukapheresis product**, which is a collection of certain blood cells, accepted for manufacturing.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer than **follicular lymphoma**. Follicular lymphoma is a type of blood cancer that affects the lymphatic system.
  • Patients who have not experienced a return of their cancer after treatment, known as **relapsed**, or whose cancer has not responded to treatment, known as **refractory**.
  • Patients who are under the age of 18. This study is for adults only.
  • Patients who are not able to give their own consent to participate in the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who have received certain treatments recently that could affect the study results.
  • Patients who have allergies to the study medication or its ingredients.
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Investigated drugs

Tisagenlecleucel is a type of therapy used in this clinical trial. It is a treatment designed to help the body's immune system fight cancer. Tisagenlecleucel is a form of CAR-T cell therapy, where a patient's own T-cells (a type of white blood cell) are modified in a laboratory to better recognize and attack cancer cells. This therapy is being tested for its effectiveness and safety in treating adults with follicular lymphoma that has not responded to other treatments or has returned after treatment.

What is already known about the treatment

Tisagenlecleucel – This medication is administered through an intravenous infusion and is currently being studied in clinical trials for its effectiveness in treating adult patients with refractory or relapsed follicular lymphoma. It is a form of CAR-T cell therapy, which involves modifying a patient's own T-cells to better recognize and attack cancer cells. Tisagenlecleucel is classified as an immunotherapy and works by targeting specific proteins on the surface of cancer cells, leading to their destruction. The medication is still under investigation, and its safety and efficacy are being evaluated in ongoing studies.

Investigated diseases

Follicular Lymphoma – Follicular lymphoma is a type of non-Hodgkin lymphoma, which is a cancer that starts in the white blood cells called lymphocytes. It typically progresses slowly and is characterized by the formation of tumors in the lymph nodes. Over time, it can spread to other parts of the body, including the bone marrow and spleen. Patients may experience symptoms such as painless swelling of lymph nodes, fatigue, and night sweats. The disease is often diagnosed in adults and can be challenging to treat if it becomes refractory or relapses after initial therapy.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508127-13-00Protocol codeCCTL019E2202Estimated enrolment97 patientsSponsorNovartis Pharma AG

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