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Study of drug combination therapy in children and adolescents with relapsed or refractory B-cell non-Hodgkin lymphoma using odronextamab, loncastuximab tesirine and rituximab

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 studying treatments for B-cell Non-Hodgkin Lymphoma that has come back or not responded to previous treatments in children and young adults. The study will test several medications including odronextamab, loncastuximab tesirine, and combinations of chemotherapy drugs including rituximab, ifosfamide, carboplatin, etoposide, and dexamethasone.

The purpose of this study is to evaluate how well these treatments work in patients whose lymphoma has returned or did not respond to initial treatment. The study is divided into different treatment groups, with some patients receiving new targeted therapies while others receive combinations of standard chemotherapy medications.

During the study, patients will receive their assigned treatment and have regular medical evaluations to check how well the treatment is working. The treatment period may last up to 24 months, depending on which medication group the patient is assigned to. Doctors will monitor patients' response to treatment using imaging scans and other medical tests to assess if the cancer is responding to the therapy.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment preparation

    Your eligibility for the trial will be confirmed through medical tests, including blood tests to check bone marrow function

    A pregnancy test will be performed if applicable

    Your disease will be evaluated through imaging tests (CT or MRI) to measure the affected areas

  2. Step 2

    Treatment assignment

    You will be assigned to one of three treatment groups:

    Treatment Arm I: Treatment with a medication called odronextamab given by intravenous infusion

    Treatment Arm II: Treatment with a combination of medications including rituximab, ifosfamide, carboplatin, etoposide, and dexamethasone (modified R-ICE), given by infusion

    Treatment Arm III: CAR T-cell therapy for eligible patients

  3. Step 3

    Treatment period

    For Treatment Arm I: Treatment will be evaluated after 12 weeks to check if there is improvement in your condition

    For Treatment Arm II: You will receive up to three cycles of treatment

    Regular imaging tests will be performed to monitor how your disease responds to treatment

    Blood tests will be conducted to monitor your health during treatment

  4. Step 4

    Follow-up period

    Your health will be monitored for any side effects from the treatment

    Regular check-ups will track how long the treatment response lasts

    Long-term monitoring will continue to assess your overall health and disease status

Who can join the trial?

12 criteria

  • Patient must have confirmed mature B-cell non-Hodgkin Lymphoma (a type of blood cancer) that has either come back after treatment or did not respond to previous treatments
  • Patient must be from birth to 25 years old at the time of joining the study
  • Patient must have disease that can be measured through scans or bone marrow tests
  • Patient must have good enough physical function (ability to perform daily activities)
  • Patient must have a life expectancy of at least 8 weeks

  • Patient must have adequate blood cell counts:

    • Sufficient platelets (cells that help blood clot)
    • Sufficient neutrophils (white blood cells that fight infection)
  • Female patients who can become pregnant must have a negative pregnancy test within 7 days before starting

  • Patients who can have children must:

    • Use effective birth control during treatment and for 12 months after
    • Not donate eggs or sperm during treatment and for 12 months after
  • Patient must have adequate kidney function
  • Patient must have adequate liver function
  • If patient had previous cell therapy treatments, they must have recovered from side effects and still have measurable disease
  • Patient or their legal guardian must provide written informed consent

Who cannot join the trial?

15 criteria

  • Active central nervous system disease, including brain or spinal cord involvement
  • History of other cancer types within the past 3 years (except for successfully treated skin cancer or early-stage cervical cancer)
  • Severe heart problems, including heart failure (when heart cannot pump blood effectively) or uncontrolled irregular heartbeat
  • Severe lung problems that affect breathing
  • Active infections requiring treatment, including hepatitis B, hepatitis C, or HIV
  • Severe liver problems affecting liver function
  • Severe kidney problems affecting kidney function
  • Pregnancy or breastfeeding
  • Previous treatment with similar therapy in the past 30 days
  • Mental conditions that would interfere with understanding study requirements
  • Participation in another clinical trial within the past 30 days
  • Known allergic reactions to study medications or similar compounds
  • Uncontrolled high blood pressure
  • Major surgery within the past 4 weeks
  • Any condition that the study doctor believes would make participation unsafe
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Investigated drugs

BsAb (Bispecific Antibody) is a type of treatment that helps the body's immune system fight cancer cells. It works by connecting immune cells to cancer cells, making it easier for the immune system to recognize and destroy the cancer. Rituximab is a medication that targets specific proteins on B-cells (a type of white blood cell) to help fight lymphoma. It works with the body's immune system to kill cancer cells. Ifosfamide is a chemotherapy medication that works by stopping cancer cells from growing and dividing. Carboplatin is a chemotherapy medication that interferes with cancer cell DNA, preventing cancer cells from multiplying. Etoposide is a chemotherapy medication that blocks enzymes needed for cancer cell growth, causing the cells to die. Dexamethasone is a steroid medication that helps reduce inflammation and suppress immune system responses, often used alongside chemotherapy to help manage side effects. CAR T-cell therapy is a treatment where a patient's own immune cells (T-cells) are modified in a laboratory to better recognize and fight cancer cells. These modified cells are then returned to the patient's body to attack the lymphoma. ADC (Antibody-Drug Conjugate) is a targeted therapy that combines an antibody with a chemotherapy drug. The antibody helps deliver the chemotherapy directly to cancer cells, potentially reducing side effects on healthy cells.

What is already known about the treatment

  • Rituximab

    An intravenously administered monoclonal antibody used in combination therapy for relapsed and refractory B-cell non-Hodgkin Lymphoma. It works by targeting CD20 proteins on B-cells, triggering the immune system to destroy these cells. This medication belongs to the class of targeted immunotherapy agents and is commonly used as part of the R-ICE chemotherapy regimen.

  • Ifosfamide

    An intravenous chemotherapy medication that belongs to the alkylating agents class, used as part of the R-ICE combination therapy for relapsed non-Hodgkin Lymphoma. It works by damaging the DNA of cancer cells, preventing them from dividing and growing. This medication is typically administered in hospital settings under careful monitoring.

  • Carboplatin

    An intravenous platinum-based chemotherapy drug used in the R-ICE regimen for treating relapsed lymphoma. It functions by binding to DNA and interfering with cell division, particularly targeting fast-growing cancer cells. This medication belongs to the platinum coordination complex class of chemotherapy drugs.

  • Etoposide

    An intravenous chemotherapy medication that is part of the R-ICE protocol for treating relapsed lymphoma. It works by blocking an enzyme called topoisomerase II, which is essential for cancer cell division and growth. This medication belongs to the topoisomerase inhibitor class and is administered under careful medical supervision.

  • Dexamethasone

    A corticosteroid medication that can be given orally or intravenously as part of the R-ICE regimen for lymphoma treatment. It helps reduce inflammation and suppress immune responses that may interfere with treatment, while also having direct effects against lymphoma cells. This medication belongs to the glucocorticoid class and helps manage treatment-related side effects.

Investigated diseases

Non-Hodgkin Lymphoma - A type of blood cancer that starts in white blood cells called lymphocytes, which are part of the body's immune system. The disease occurs when abnormal lymphocytes grow and multiply uncontrollably, usually beginning in lymph nodes or other lymphatic tissue. In mature B-cell non-Hodgkin lymphoma specifically, the cancer develops in B lymphocytes that have reached their mature form. The disease can spread throughout the lymphatic system, affecting multiple areas of the body. When the condition becomes relapsed and refractory, it means the lymphoma has returned after treatment or has stopped responding to standard treatments.
Trial detailsLast updated 30 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-510575-38-00Protocol codeRG_21-124Estimated enrolment224 patientsSponsorThe University Of Birmingham

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