A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy

Running, not enrolling · Phase 2

Conditions studied: Glioma

In brief

The purpose of this study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy. Your participation could last approximately 11 months and possibly longer depending upon how you and your tumor respond.

Key facts

Study ID

NCT06413706

Run by

Eli Lilly and Company

People needed

45

Starts

2024-10-25

Expected to finish

2028-02-01

Last updated by the study team

2026-07-17

Who can join

Age: any, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Biopsy proven high-grade glioma (HGG) as defined by 2016 World Health Organization (WHO) Classification Criteria, Grade 3-4 including:
• Anaplastic astrocytoma
• Anaplastic ganglioglioma
• Anaplastic oligodendroglioma.
• Anaplastic pleomorphic xanthoastrocytoma,
• Glioblastoma
• OR as defined by the 2021 WHO Classification Criteria as molecularly characterized:
• Non-pontine diffuse midline glioma, H3 K27-altered,
• Diffuse hemispheric glioma, H3 G34-mutant
• Diffuse pediatric HGG, H3/IDH-wildtype
• Infant-type hemispheric glioma
• High-grade astrocytoma with piloid features
• High-grade pleomorphic xanthoastrocytoma
• IDH-mutant diffuse glioma with homozygous cyclin- dependent kinase inhibitor 2A/B (CDKN2A/B) deletion,
• IDH-mutant and 1p/19q co-deleted oligodendroglioma
• IDH-mutant astrocytoma with homozygous CDKN2A/B deletion
• Contraceptive use should be consistent with local regulations for participants in clinical studies.
• Radiotherapy initiated within 6 weeks (+1 week) of diagnosis and administered over 6 weeks (±1 week). Participants <3 years of age, considered not suitable for radiotherapy may be eligible.
• Minimum of 4 weeks between completion of radiation and Cycle 1 Day 1 (C1D1).
• Maximum of 8 weeks between completion of radiation and C1D1. Exceptional circumstances can be discussed with the medical monitor.
• Acute effects of prior therapies must be Grade ≤1 unless deemed clinically insignificant by the investigator.
• Adequate hematologic and organ function ≤7 days prior to C1D1
• Life expectancy of ≥8 weeks and deemed likely to complete at least 1 cycle of treatment.
• A performance score of ≥60 using:
• Lansky scale for participants <16 years

You may not qualify if…

• Participants are excluded if any of the following apply:
• Diffuse Intrinsic Pontine Glioma (DIPG) or diffuse midline glioma located in the pons.
• Recurrent or refractory HGG including any recurrence/progression during/after radiotherapy.
• Secondary HGG, defined as a previously treated low-grade glioma that now meets high- grade criteria, or that resulted from a previously treated malignancy.
• Have known pathogenic somatic mutations appropriate for an anaplastic lymphoma kinase (ALK), B-rapidly accelerated fibrosarcoma (BRAF), or neurotrophic tyrosine receptor kinase (NTRK ) inhibitor, in regions where these therapies are available and deemed appropriate by the investigator.
• Prior HGG treatment (including bevacizumab), except for surgery and radiotherapy (with or without concomitant temozolomide).
• Current enrollment in another trial deemed incompatible with this study.
• Treatment with an investigational product within the last 30 days or 5 half-lives (whichever is longer).
• Prior malignancy within the previous 3 years that, per the investigator and the medical monitor, may affect interpretation of study results.
• A preexisting medical condition(s) that, per the investigator, would preclude study participation.
• Any serious, active, systemic infection requiring IV antibiotic, antifungal, or antiviral therapy, including acute hepatitis B or C, or Human Immunodeficiency Virus at C1D1.
• Intolerability or hypersensitivity such as urticaria, anaphylaxis, toxic necrolysis, and/or Stevens-Johnson syndrome to temozolomide, and/or abemaciclib, their excipients, or dacarbazine.
• Received a live virus vaccine within 28 days of C1D1.
• Pregnant, breastfeeding, or intend to become pregnant during the study.

Where it is running

• Children's Hospital of Orange County - Orange — Orange, California, United States
• Lucile Packard Children's Hospital (LPCH) - Stanford University — Palo Alto, California, United States
• Riley Hospital for Children at Indiana University Health — Indianapolis, Indiana, United States
• The Johns Hopkins Hospital (JHH) - Johns Hopkins Childrens Center — Baltimore, Maryland, United States
• University of Michigan Health System (UMHS) - C.S. Mott Children's Hospital - Hematology Oncology Clinic — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• UT Southwestern Medical Center Dallas/Childrens Medical Center — Dallas, Texas, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Queensland Government- Lady Cilento Children's Hospital — Brisbane, Australia
• Perth Children's Hospital — Nedlands, Australia
• The Children's Hospital at Westmead — Westmead, Australia
• Universitair Ziekenhuis Gent (Uz Gent) — Ghent, Belgium
• Universitair Ziekenhuis Leuven — Leuven, Belgium
• Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc — Woluwe-Saint-Lambert, Belgium
• Copenhagen University Hospital-Rigshospitalet University Hospital — Copenhagen, Denmark
• Centre Hospitalier Universitaire de Bordeaux Groupe Hospitalier Pellegrin Hopital des Enfants — Bordeaux, France
• Centre de Lutte Contre le Cancer (CLCC) - Centre Oscar Lambret — Lille, France
• Centre Leon Berard — Lyon, France
• Hopital La Timone — Marseille, France
• Institut Curie — Paris, France
• Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP — Villejuif, France
• Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Italy
• Azienda Ospedaliera Di Rilievo Nazionale Santobono Pausilipon — Naples, Italy
• IRCCS Ospedale Pediatrico Bambino Gesu — Rome, Italy

Full record on ClinicalTrials.gov

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