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Study of Abemaciclib and Temozolomide for Children and Young Adults with Newly Diagnosed High-Grade Glioma After Radiotherapy

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 brain cancer called high-grade glioma in children and young adults. The study will explore the effects of a treatment that combines two medications: Abemaciclib and Temozolomide. Abemaciclib, also known by its code name LY2835219, is a medication that comes in the form of tablets or granules and is taken by mouth. Temozolomide is another medication used in this study, also taken orally.

The purpose of the study is to determine if adding Abemaciclib to the standard chemotherapy treatment with Temozolomide can provide additional benefits for patients who have been newly diagnosed with high-grade glioma and have already undergone radiotherapy. Radiotherapy is a treatment that uses high-energy rays to target and kill cancer cells. The study will compare the combination of Abemaciclib and Temozolomide to the use of Temozolomide alone.

Participants in the study will receive either the combination treatment or Temozolomide alone. The study will monitor the participants over a period to assess the effectiveness of the treatments. The goal is to see if the combination treatment can improve outcomes for patients with high-grade glioma. The study will involve regular check-ups, including lab tests and imaging of the tumor, to track the progress and effects of the treatment.

The research process

The trial runs in 5 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. This includes having a diagnosis of high-grade glioma and having undergone prior radiotherapy. Participants must be able to swallow or have a feeding tube and be willing to follow study procedures.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to ensure recovery from major side effects of previous therapy. Adequate organ function and blood counts are confirmed through lab tests.

  3. Step 3

    Treatment phase

    The treatment phase involves taking medications orally. Participants receive either abemaciclib in combination with temozolomide or temozolomide alone. The specific dosage and frequency are determined by the study protocol.

  4. Step 4

    Ongoing monitoring

    Throughout the study, frequent lab tests and tumor imaging are conducted to monitor health and response to treatment. This helps in assessing the benefit of adding abemaciclib to the chemotherapy regimen.

  5. Step 5

    Completion of study

    The study is estimated to conclude by May 12, 2028. Participants' progress is evaluated based on event-free survival, as determined by an independent review committee.

Who can join the trial?

5 criteria

  • Have a type of brain tumor called high-grade glioma.
  • Have received radiotherapy (a treatment using high-energy rays) before, with or without a medicine called temozolomide. If under 3 years old, may not need prior radiotherapy.
  • Have recovered from major side effects of previous treatments and have organs and blood in good condition, as shown by lab tests.
  • Be able to swallow or have a feeding tube to take medicines.
  • Be willing and able to follow the study's procedures, which include frequent lab tests and imaging of the tumor.

Who cannot join the trial?

5 criteria

  • Patients who have not been diagnosed with a high-grade **glioma**. A glioma is a type of tumor that occurs in the brain and spinal cord.
  • Patients who have not completed **radiotherapy**. Radiotherapy is a treatment that uses high doses of radiation to kill cancer cells and shrink tumors.
  • Patients who are not within the specified age range for the study. The study is open to certain age groups only.
  • Patients who are not able to take the study medications, **abemaciclib** and **temozolomide**. These are drugs used in cancer treatment.
  • Patients who are part of a vulnerable population that the study is not designed to include. Vulnerable populations may include groups like children, pregnant women, or others who need special protection.
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Investigated drugs

  • Abemaciclib

    is a medication being studied for its potential to help treat high-grade glioma, a type of brain tumor, in children and young adults. It is being tested to see if it can improve the effectiveness of the standard chemotherapy treatment when used in combination with another drug.

  • Temozolomide

    is a chemotherapy drug commonly used to treat certain types of brain tumors, including high-grade glioma. In this study, it is being used both alone and in combination with abemaciclib to determine if the combination provides better outcomes for patients.

What is already known about the treatment

  • Abemaciclib

    Abemaciclib is administered orally in the form of tablets. It is currently being studied in clinical trials for its potential use in treating high-grade glioma, particularly in combination with other treatments. The main therapeutic indication for abemaciclib in this context is to enhance the effectiveness of chemotherapy in children and young adults with newly diagnosed high-grade glioma following radiotherapy. At the molecular level, abemaciclib works by inhibiting certain proteins called cyclin-dependent kinases, which are involved in cell division, thereby slowing down the growth of cancer cells. It is classified as a CDK inhibitor in pharmacology.

  • Temozolomide

    Temozolomide is an oral medication, typically taken in capsule form. It is an established treatment in the medical field for certain types of brain tumors, including high-grade glioma. The primary therapeutic use of temozolomide is to treat brain tumors by interfering with the DNA of cancer cells, which prevents them from multiplying. This medication is classified as an alkylating agent, which means it works by adding an alkyl group to the DNA, leading to cell death.

Investigated diseases

Glioma – Glioma is a type of tumor that occurs in the brain and spinal cord. It originates from glial cells, which are supportive cells in the nervous system. Gliomas can vary in their growth rate and are classified into different grades, with high-grade gliomas being more aggressive. As the tumor grows, it can cause symptoms such as headaches, seizures, and neurological deficits depending on its location. The progression of glioma can lead to increased pressure within the skull and affect brain function. The specific symptoms and progression depend on the tumor's size, location, and growth rate.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502269-13-00Protocol codeI3Y-MC-JPEHEstimated enrolment52 patientsSponsorEli Lilly & Co.

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