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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
IRCCS Istituto Giannina Gaslini Genoa Italy
Universitair Ziekenhuis Gent Gent Belgium
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Centre Hospitalier Regional De La Citadelle Liege Belgium
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Bucharest Romania
Azienda Ospedaliera Santobono Pausilipon Naples Italy
Virgen del Rocío University Hospital Sevilla Spain
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Prinses Maxima Centrum voor Kinderoncologie B.V. Utrecht The Netherlands
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Rigshospitalet Copenhagen Denmark
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Hospital Universitario Hm Monteprincipe Boadilla Del Monte Spain
Cczvnjwwv Ukfspctigwifgx Shjnxrwar Woluwe-Saint-Lambert Belgium
Ccbmps Leme Bwunzu Lyon France
Atzzfvqlvi Pjhafkrr Hjgdxddm Dg Metahudvz Marseille France
Acomtjk Onbsqqruqju Uxerdfotkxwzo Cqsfzvebcngc Dzmin Sznwgq E Dlxly Sllcjsr Da Tmefim Turin Italy
Cifw Dp Nablz Vandoeuvre Les Nancy France
Cacusj Hzulvlirmda Rumuwmsp Djpaikyblqueea Angers France
Frmlbgtgf Ppfq Ls Iivdbpwabgbwz Bghilwhew Dcl Hwzectyq Uomfwvpefagjq Lb Pwv Madrid Spain
Hbyroggm Vbzm dvzpctne Barcelona Spain
Ccugrk Ounts Ledrcxz Lille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
20.08.2024
Denmark Denmark
Not recruiting
20.08.2024
France France
Not recruiting
20.08.2024
Italy Italy
Not recruiting
20.08.2024
Romania Romania
Not recruiting
20.08.2024
Spain Spain
Not recruiting
20.08.2024
The Netherlands The Netherlands
Not recruiting
20.08.2024

Trial locations

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.

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 ID:
2022-502269-13-00
Protocol code:
I3Y-MC-JPEH
Trial Phase:
Therapeutic exploratory (Phase II)

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