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Study of Brigatinib for Children and Young Adults with ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors, or Other Solid Tumors

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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 effects of a medication called Brigatinib in children and young adults who have certain types of cancer. The cancers being studied include Anaplastic Large Cell Lymphoma (ALCL), Inflammatory Myofibroblastic Tumors (IMT), and other solid tumors. Brigatinib is taken in the form of film-coated tablets and is being tested to see how well it works in treating these cancers.

The purpose of the study is to find the best dose of Brigatinib for young patients and to understand how the body processes the medication. The study will also look at how effective Brigatinib is in shrinking tumors and improving the health of patients with these specific types of cancer. Participants in the study will take the medication and be monitored by healthcare professionals over a period of time to observe any changes in their condition.

During the study, some participants may receive a placebo, which is a substance with no active medication, to compare the effects of Brigatinib. The study aims to gather important information that could help improve treatment options for young patients with these cancers in the future. The trial is expected to continue until 2030, allowing researchers to collect comprehensive data on the medication's safety and effectiveness.

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 phase

    The study involves the use of the medication brigatinib, which is available in film-coated tablets of 30 mg, 90 mg, and 180 mg. The medication is taken orally.

    The initial phase of the study aims to determine the most suitable dosage of brigatinib for pediatric and young adult patients with specific types of cancer, including ALK+ Anaplastic Large Cell Lymphoma (ALCL), Inflammatory Myofibroblastic Tumors (IMT), or other solid tumors.

    During this phase, the focus is on identifying any dose-limiting side effects and understanding how the body processes the medication.

  2. Step 2

    Dose determination

    The appropriate dosage of brigatinib is determined based on how the medication is absorbed and processed in the body, aiming for a dosage that is similar to that used in adults but adjusted for younger patients.

    The decision on the recommended dosage is made by a board of experts, considering both the body's response to the medication and any side effects observed.

  3. Step 3

    Treatment evaluation

    The effectiveness of brigatinib is evaluated by observing the response of the cancer to the treatment. This includes measuring the size of the tumor and monitoring any changes in the patient's condition.

    The study also assesses the overall response rate, which is the percentage of patients who experience a significant reduction in tumor size or complete disappearance of the tumor.

  4. Step 4

    Long-term treatment

    For patients with ALK+ ALCL, the treatment with brigatinib is planned to continue for a duration of up to two years, provided the patient continues to benefit from the treatment without significant side effects.

    The study aims to establish the long-term effectiveness of brigatinib in managing the cancer without the need for additional treatments such as stem cell transplants.

Who can join the trial?

11 criteria

  • Patients must be at least 1 year old and younger than 26 years old at the time of joining the study. They should be able to swallow the study medication tablets and weigh at least 10 kg.
  • Patients need to have a confirmed diagnosis of cancer. If a new biopsy is not possible, previous samples from the initial diagnosis should be available for review.
  • Patients must have test results showing a change in the ALK gene in their tumor. This can be confirmed by different tests like IHC, FISH, PCR, or NGS. For ALK+ ALCL, a specific test called immunohistochemistry (IHC) is enough.
  • For Phase 1:
    • Patients with ALCL should have cancer that has returned or not responded to standard treatments. This means no improvement after at least one round of standard chemotherapy or specific test results showing the disease is still present.
    • Patients with IMT should not be able to have surgery without causing severe harm. Newly diagnosed patients with advanced IMT, where surgery is not possible due to the tumor's location, can also join.
    • Patients with other solid tumors must have cancer that has returned or not responded to treatment.
    • For Phase 2:
      • Patients with ALCL should have cancer that has returned or not responded to treatment, similar to Phase 1.
      • Patients with IMT should have cancer that has returned or is newly diagnosed and cannot be surgically removed without causing severe harm.
      • Patients must have a certain level of physical ability:
        • For patients older than 16 years, they should have a Karnofsky performance status of at least 40% for ALCL patients in Phase 2, and at least 50% for IMT, other solid tumors, and ALCL patients in Phase 1.
        • For patients 16 years or younger, they should have a Lansky Play Scale of at least 40% for ALCL patients in Phase 2, and at least 50% for IMT, other solid tumors, and ALCL patients in Phase 1.
        • Patients must not be taking any other experimental medications or treatments, including herbal therapies, within 30 days before starting the study medication or during the study.

Who cannot join the trial?

4 criteria

  • Patients who do not have a diagnosis of Anaplastic Large Cell Lymphoma (ALCL), Inflammatory Myofibroblastic Tumors (IMT), or other solid tumors cannot participate. Solid tumors are abnormal masses of tissue that usually do not contain liquid areas.
  • Patients who are not within the specified age range for the study cannot participate. The study is for certain age groups, which are not specified here.
  • Patients who are not identified as either male or female cannot participate, as the study includes both genders.
  • Patients who are not considered part of a vulnerable population cannot participate. A vulnerable population includes groups that may need special protection or care.
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Investigated drugs

Brigatinib is a medication being studied for its effectiveness in treating certain types of cancer in children and young adults. It is used in patients who have a specific genetic marker known as ALK+ (anaplastic lymphoma kinase positive). This includes conditions like Anaplastic Large Cell Lymphoma (ALCL), Inflammatory Myofibroblastic Tumors (IMT), and other solid tumors. The study aims to find the best dose of brigatinib for these patients and to understand how the body processes the medication. Additionally, the study is looking at how well brigatinib works in shrinking tumors and improving patient outcomes over a period of two years.

What is already known about the treatment

Brigatinib – Brigatinib is administered orally in tablet form and is currently being studied in clinical trials for its effectiveness in treating certain types of cancer, specifically ALK-positive Anaplastic Large Cell Lymphoma (ALCL), Inflammatory Myofibroblastic Tumors (IMT), and other solid tumors. It is classified as a tyrosine kinase inhibitor, which works by blocking specific proteins involved in the growth and spread of cancer cells. This medication is being evaluated for its ability to determine the maximum tolerated dose and to assess its pharmacokinetics and anti-tumor activity in pediatric and young adult patients.

Investigated diseases

  • Anaplastic Large Cell Lymphoma (ALCL)

    This is a type of non-Hodgkin lymphoma characterized by the presence of large, abnormal lymphocytes. It often begins in the lymph nodes but can also affect other parts of the body. The disease can progress by spreading to other lymph nodes and organs. Symptoms may include swollen lymph nodes, fever, and weight loss. ALCL is associated with a specific genetic mutation involving the ALK gene. The progression can vary, with some cases being more aggressive than others.

  • Inflammatory Myofibroblastic Tumors (IMT)

    These are rare tumors that can occur in various parts of the body, including the lungs, abdomen, and pelvis. They are characterized by the proliferation of myofibroblastic cells and inflammatory cells. IMTs can grow slowly and may cause symptoms depending on their location, such as pain or swelling. The tumors are often associated with genetic changes involving the ALK gene. While they are generally considered benign, they can sometimes behave aggressively. The progression of IMT can vary, with some tumors remaining stable for long periods.

  • Other Solid Tumors

    This term refers to a diverse group of cancers that form solid masses in various tissues and organs. These tumors can arise in any part of the body, such as the lungs, liver, or bones. The progression of solid tumors depends on the type and location, with some growing slowly and others more rapidly. Symptoms vary widely based on the tumor's location and size, potentially causing pain, swelling, or organ dysfunction. Genetic mutations, including those involving the ALK gene, can play a role in the development of these tumors. The behavior and progression of solid tumors can be unpredictable, requiring careful monitoring.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-513412-10-00Protocol codeBrigaPED ITCC-098Estimated enrolment68 patientsSponsorPrincess Maxima Center For Pediatric Oncology

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