A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy
NCT ID: NCT06413706
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
45 participants
INTERVENTIONAL
2024-10-25
2028-02-29
Brief Summary
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Your participation could last approximately 11 months and possibly longer depending upon how you and your tumor respond.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Abemaciclib + Temozolomide - Arm A
Participants will receive abemaciclib administered orally in addition to temozolomide administered orally or intravenously (IV).
Abemaciclib
Administered orally
Temozolomide
Administered orally or IV
Temozolomide - Arm B
Participants will receive temozolomide administered orally or IV.
Temozolomide
Administered orally or IV
Interventions
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Abemaciclib
Administered orally
Temozolomide
Administered orally or IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
1. Lansky scale for participants \<16 years
2. Karnofsky scale for participants ≥16 years
* Able to swallow and/or have a gastric/nasogastric tube.
* Any current systemic steroid use dose must be stable or decreasing at least 7 days prior to C1D1.
* Able and willing to adhere to study procedures, including frequent blood draws and MRI.
* At least 28 days since any major surgery, laparoscopic procedure, or a significant traumatic injury.
* Has a body surface area (BSA) of ≥0.2 m2.
Exclusion Criteria
* 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.
0 Years
20 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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University of Alabama at Birmingham (UAB) - Children's Hospital - The Alabama Center for Childhood Cancer and Blood -T
Birmingham, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
University Of California - San Diego Moores Cancer Center
La Jolla, California, United States
Children's Hospital of Orange County - Orange
Orange, California, United States
Lucile Packard Children's Hospital (LPCH) - Stanford University
Palo Alto, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Nicklaus Children's Hospital
Miami, Florida, United States
The University of Chicago Medicine
Chicago, Illinois, United States
Indiana University Health - Riley Hospital for Children - Riley Hospital Outpatient Center (ROC) - IUPUI campus
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
Corewell Health, Helen DeVos Childrens Hospital Hematology and Oncology
Grand Rapids, Michigan, United States
University of Minnesota / Masonic Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Oregon Health and Science University (OHSU) - Doernbecher Children's Hospital
Portland, Oregon, 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
The University of Texas Health Science Center at San Antonio
San Antonio, 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
Ghent, , Belgium
Universitair Ziekenhuis Leuven
Leuven, , Belgium
Centre Hospitalier Regional CHR de la Citadelle
Liège, , 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 d'Angers (CHU Angers)
Angers, , France
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
CHU de Nancy Hopitaux de Brabois
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP
Villejuif, , France
IRCCS - AOU di Bologna - Sant¿Orsola Malpighi
Bologna, , Italy
Instituto Giannina Gaslini
Genova, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, , Italy
Azienda Ospedaliera Di Rilievo Nazionale Santobono Pausilipon
Naples, , Italy
Instituto Oncologico Veneto
Padua, , Italy
Universita Di Padova
Padua, , Italy
IRCCS Ospedale Pediatrico Bambino Gesu
Rome, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Rome, , Italy
A.O.U. Citta della Salute e della Scienza di Torino - Ospedale Infantile Regina Margherita
Torino, , Italy
Nagoya University Hospital
Nagoya, , Japan
Osaka City General Hospital
Osaka, , Japan
National Center for Child Health and Development (NCCHD)
Setagaya-Ku Tokyo, , Japan
Princess Maxima Center for Voor Kinderoncologie B.V
Utrecht, , Netherlands
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti (IOB)
Bucharest, , Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta
Cluj-Napoca, , Romania
Centro de Esclerosis Mutiple de Cataluna (Cemcat) - Barcelona, ¿¿Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Clinico Universitario Virgen de la Arrixaca
El Palmar, , Spain
Hospital Sant Joan de Deu Barcelona
Esplugues de Llobregat, , Spain
Hospital Infantil Universitario Nino Jesus (HIUNJS)
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
START Madrid CIOCC Hospital Universitario HM Sanchinarro
Madrid, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia, , Spain
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Phone: 1-317-615-4559
Email: [email protected]
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Email: [email protected]
Facility Contacts
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Other Identifiers
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I3Y-MC-JPEH
Identifier Type: OTHER
Identifier Source: secondary_id
2022-502269-13-00
Identifier Type: CTIS
Identifier Source: secondary_id
U1111-1289-0405
Identifier Type: OTHER
Identifier Source: secondary_id
18646
Identifier Type: -
Identifier Source: org_study_id