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Study on Nivolumab and Tisagenlecleucel for Children, Adolescents, and Young Adults with Acute Lymphoblastic Leukemia After Treatment Loss

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 blood cancer called Acute Lymphoblastic Leukemia (ALL) in children, adolescents, and young adults. The study involves two treatments: Nivolumab, also known by its brand name Opdivo, and Tisagenlecleucel, known as Kymriah. Nivolumab is a medication that helps the immune system attack cancer cells, while Tisagenlecleucel is a type of cell therapy that uses modified immune cells to target and destroy cancer cells.

The purpose of the study is to determine the safety and effectiveness of combining these two treatments in patients who have previously been treated with Tisagenlecleucel but have experienced a return of their leukemia. The study will explore different timing options for starting Nivolumab to find the safest and most effective approach. Participants will receive these treatments through an intravenous infusion, which means the medication is given directly into a vein.

Throughout the study, researchers will monitor participants for any side effects and assess how well the treatments are working. The study aims to improve understanding of how these treatments can be used together to help patients with relapsed or difficult-to-treat ALL. The trial will take place over several years, with regular follow-ups to track the long-term effects and benefits of the treatment combination.

The research process

The trial runs in 8 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, eligibility is confirmed based on specific criteria, including age and medical history related to acute lymphoblastic leukemia.

    Informed consent is required before participation.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the current health status and confirm the absence of organ dysfunction.

    Life expectancy is assessed to ensure it exceeds 12 weeks.

  3. Step 3

    Treatment preparation

    Preparation for treatment involves ensuring the availability of a second dose of tisagenlecleucel (Kymriah®).

    The treatment plan is tailored based on the cohort classification, which depends on the patient's disease status and previous treatment response.

  4. Step 4

    Nivolumab administration

    The administration of nivolumab (Opdivo®) is scheduled at one of four possible time points: day 14, day 11, day 5, or day -1, depending on the cohort.

    Nivolumab is given as an intravenous infusion, which involves delivering the medication directly into the bloodstream.

  5. Step 5

    Tisagenlecleucel reinfusion

    Following nivolumab administration, tisagenlecleucel is reinfused.

    This step is crucial for patients who have experienced a loss of B-cell aplasia, a condition where B cells are not present in the blood.

  6. Step 6

    Monitoring and evaluation

    Patients are monitored for any limiting toxicities from the time of infusion until day 28.

    Efficacy is evaluated at three months post-reinfusion, focusing on achieving minimal residual disease (MRD) negative complete remission and B-cell aplasia.

  7. Step 7

    Follow-up assessments

    Regular follow-up assessments occur at one, three, six, and twelve months after reinfusion to monitor disease response and remission status.

    Long-term follow-up includes evaluating overall survival and event-free survival up to two years.

  8. Step 8

    Completion of study

    The study is estimated to conclude by March 15, 2027.

    Final assessments will determine the long-term efficacy and safety of the treatment combination.

Who can join the trial?

10 criteria

  • Patients must be between 1 to 25 years old.
  • Must have a history of a type of blood cancer called **CD19+ relapsed or refractory B-ALL**. This includes any relapse after a bone marrow transplant, a second relapse or later, or if the cancer does not respond to treatment.
  • Must have a second dose of a treatment called **tisagenlecleucel (Kymriah®)** available.
  • For **Cohort 1**: Patients must have been treated with tisagenlecleucel and show an early loss of **B-cell aplasia**. This means having less than 10 B cells per cubic millimeter of blood or less than 3% of total lymphocytes within 6 months after treatment, while still being in **complete remission (CR)** with no detectable **minimal residual disease (MRD)**.
  • For **Cohort 2**: Patients must have been treated with tisagenlecleucel and show a loss of B-cell aplasia, with detectable **CD19+ ALL** in the bone marrow, blood, or cerebrospinal fluid (CSF).
  • Patients must have a life expectancy of more than 12 weeks.
  • Patients older than 16 must have a **Karnofsky score** greater than 70, and those younger than 16 must have a **Lansky score** greater than 70. These scores measure the patient's ability to perform daily activities.
  • Patients must not have any organ dysfunction.
  • Patients must have signed an informed consent form.
  • Patients must be affiliated with social security or have health insurance.

Who cannot join the trial?

5 criteria

  • Patients who are not between the ages of 1 and 25 years old.
  • Patients who have not been previously treated with tisagenlecleucel (Kymriah®).
  • Patients who do not have a demonstrated early loss of B-cell aplasia within 6 months. B-cell aplasia means a lack of B-cells, which are a type of white blood cell important for the immune system.
  • Patients who are not diagnosed with relapsed or refractory B-ALL. Relapsed means the cancer has returned after treatment, and refractory means the cancer does not respond to treatment.
  • Patients who are not able to start Nivolumab (Opdivo®) treatment at the specified time points.
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Investigated drugs

  • Nivolumab (Opdivo®)

    is a medication used in this trial as an anti-PD1 treatment. It is designed to help the immune system recognize and attack cancer cells. In this study, it is being tested for its safety and effectiveness when combined with another treatment in young patients with a type of leukemia that has returned or not responded to previous treatments.

  • Tisagenlecleucel (Kymriah®)

    is a type of therapy known as CAR T-cell therapy. It involves modifying a patient's own immune cells to better recognize and fight cancer cells. In this trial, it is being used in combination with Nivolumab to see if this approach can improve outcomes for patients who have experienced a loss of the therapy's effectiveness.

What is already known about the treatment

  • Nivolumab

    Nivolumab is administered as an intravenous infusion and is currently being studied in combination with tisagenlecleucel for treating children, adolescents, and young adults with Acute Lymphoblastic Leukemia (ALL) who have relapsed or have refractory disease. It is an anti-PD1 antibody that works by blocking the PD-1 protein on immune cells, enhancing the body's immune response against cancer cells. Nivolumab is classified as an immune checkpoint inhibitor and is being evaluated for its safety and effectiveness in this specific patient group.

  • Tisagenlecleucel

    Tisagenlecleucel is administered through an intravenous infusion and is a form of CAR T-cell therapy used in treating certain types of leukemia, including Acute Lymphoblastic Leukemia (ALL) in young patients. It involves modifying a patient's T-cells to better recognize and attack cancer cells. This therapy is classified as a gene therapy and is being studied in combination with nivolumab to improve outcomes in patients who have experienced a loss of CAR T-cell persistence.

Investigated diseases

Acute Lymphoblastic Leukemia – Acute Lymphoblastic Leukemia (ALL) is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of immature white blood cells, known as lymphoblasts. It primarily occurs in children, adolescents, and young adults. The disease progresses rapidly, leading to symptoms such as fatigue, fever, frequent infections, and easy bruising or bleeding due to the lack of healthy blood cells. As the abnormal cells multiply, they crowd out normal cells, impairing the body's ability to fight infections and carry oxygen. The progression of ALL can vary, but it typically requires prompt medical intervention to manage the rapid increase of leukemic cells.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514345-11-00Protocol codeAPHP200132Estimated enrolment26 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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