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Study on Glofitamab and Drug Combination for Children and Young Adults with Relapsed or Refractory B-Cell Non-Hodgkin 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 B-Cell Non-Hodgkin Lymphoma, specifically in children and young adults who have experienced a return or worsening of their disease after previous treatments. The study is investigating a new treatment approach using a medication called Glofitamab, both on its own and in combination with other cancer-fighting drugs. These additional drugs include Rituximab, Ifosfamide, Carboplatin, and Etoposide, which together form a treatment regimen known as R-ICE chemoimmunotherapy. The purpose of the study is to evaluate how effective and safe this combination is in treating the disease.

Participants in the study will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein. The study is divided into two parts. In the first part, the focus is on understanding how the body processes Glofitamab and how well it works on its own. In the second part, the study looks at how Glofitamab works when combined with the R-ICE chemoimmunotherapy. The study will monitor participants for any side effects and measure how well the treatment is working against the cancer.

The trial aims to gather information on the safety and effectiveness of Glofitamab, both alone and in combination with other drugs, to see if it can help achieve a complete response, which means the cancer is no longer detectable. The study will also look at how long any positive effects last and how the treatment impacts overall survival. This research is important for developing new treatment options for young patients with relapsed or refractory B-Cell Non-Hodgkin Lymphoma.

The research process

The trial runs in 6 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, physical examination, and necessary laboratory tests to ensure adequate bone marrow, liver, and kidney function.

  2. Step 2

    Treatment cycle 1

    The first treatment cycle begins with the administration of glofitamab in combination with rituximab, ifosfamide, carboplatin, and etoposide (R-ICE chemoimmunotherapy).

    Medications are given through an intravenous (IV) infusion. The specific schedule and dosage are determined by the study protocol and the medical team.

  3. Step 3

    Monitoring and evaluation

    Throughout the treatment cycle, regular monitoring is conducted to assess the body's response to the medication. This includes physical examinations, blood tests, and imaging studies as needed.

    The occurrence of any side effects is closely monitored and managed according to the study guidelines.

  4. Step 4

    Subsequent treatment cycles

    Up to three cycles of the combination therapy may be administered, depending on the response and tolerance to the treatment.

    Each cycle is followed by a period of evaluation to determine the effectiveness of the treatment and to decide on the continuation of the therapy.

  5. Step 5

    Completion of treatment

    After completing the treatment cycles, a final assessment is conducted to evaluate the overall response to the therapy.

    This includes a comprehensive review of physical findings, laboratory results, and imaging studies to determine the achievement of a complete response.

  6. Step 6

    Follow-up

    Post-treatment follow-up is scheduled to monitor long-term outcomes and any late-onset side effects.

    Regular check-ups and tests are conducted as per the study protocol to ensure ongoing health and well-being.

Who can join the trial?

7 criteria

  • Age between 6 months and less than 18 years for Part 1 and Cohort B, and between 6 months and up to 30 years for Part 2 of the study.
  • Confirmed diagnosis of a type of cancer called **aggressive mature B-cell non-Hodgkin lymphoma** that shows a marker called **CD20**. This includes specific types like Burkitt lymphoma, Burkitt leukemia, diffuse large B-cell lymphoma, and primary mediastinal large B-cell lymphoma. The diagnosis must be confirmed by examining tissue samples.
  • The disease must be **refractory** (meaning previous treatment didn't work) or **relapsed** (meaning the disease came back) after standard treatment. For Cohort A, this means after the first treatment, and for Cohort B, after at least two treatments and no other options are available.
  • The disease must be measurable, meaning there is at least one tumor that can be measured in size, or a certain percentage of cancer cells in the bone marrow.
  • Must have a good **performance status**, which means being able to carry out daily activities, as measured by specific scales called Lansky or Karnofsky.
  • Must have proper functioning of the bone marrow, liver, and kidneys.
  • Must test negative for certain viruses: **hepatitis B**, **hepatitis C**, **HIV**, and **SARS-CoV-2** (the virus that causes COVID-19).

Who cannot join the trial?

5 criteria

  • Patients who do not have **CD20 positive B-Cell Non-Hodgkin Lymphoma** cannot participate. This is a type of cancer that affects certain white blood cells.
  • Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are not part of the specified clinical trial groups cannot participate. This refers to specific categories or groups that the trial is focusing on.
  • Patients who are not male or female cannot participate. The trial is open to both men and women.
  • Patients who are considered part of a vulnerable population cannot participate. This means people who might be at higher risk or need special protection.
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Investigated drugs

  • Glofitamab

    is a medication being studied for its ability to treat certain types of cancer, specifically relapsed or refractory mature B-cell non-Hodgkin lymphoma. It is being tested to see how well it works on its own and when combined with other cancer treatments. Researchers are looking at how safe it is for patients and how well it can help reduce or eliminate cancer cells.

  • Rituximab

    is a medication used in combination with other drugs to treat certain types of cancer, including non-Hodgkin lymphoma. It works by targeting specific cells in the immune system to help fight cancer.

  • Ifosfamide

    is a chemotherapy drug used to treat various types of cancer. It works by slowing or stopping the growth of cancer cells in the body.

  • Carboplatin

    is a chemotherapy medication used to treat different kinds of cancer. It helps to kill or stop the growth of cancer cells.

  • Etoposide

    is a chemotherapy drug that is used to treat cancer by preventing cancer cells from dividing and growing. It is often used in combination with other cancer treatments.

What is already known about the treatment

Glofitamab – Glofitamab is administered intravenously and is currently being studied in clinical trials for its effectiveness and safety in treating CD20 positive B-Cell Non-Hodgkin Lymphoma, particularly in pediatric and young adult patients with relapsed or refractory cases. It is a bispecific antibody that targets both CD20 on B-cells and CD3 on T-cells, facilitating the immune system's ability to attack cancer cells. Glofitamab is classified as an immunotherapy agent and is being evaluated both as a monotherapy and in combination with other chemoimmunotherapy agents.

Investigated diseases

CD20 Positive B-Cell Non-Hodgkin Lymphoma – This is a type of cancer that originates in the lymphatic system, specifically affecting B-cells, which are a type of white blood cell. The disease is characterized by the presence of CD20 protein on the surface of the cancerous B-cells. It typically begins with the enlargement of lymph nodes, but it can also affect other organs. As the disease progresses, it may lead to symptoms such as fever, night sweats, and unexplained weight loss. The progression can vary, with some cases advancing slowly while others may develop more rapidly. The disease is not classified as a rare condition.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-504264-41-00Protocol codeCO43810Estimated enrolment77 patientsSponsorF. Hoffmann-La Roche AG

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