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A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy
Sponsor: Eli Lilly and Company
Summary
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.
Official title: A Randomized, Open-Label, Phase 2 Study Evaluating Abemaciclib in Combination With Temozolomide Compared to Temozolomide Monotherapy in Children and Young Adults With Newly Diagnosed High-Grade Glioma Following Radiotherapy
Key Details
Gender
All
Age Range
0 Years - 20 Years
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2024-10-25
Completion Date
2028-02
Last Updated
2026-03-24
Healthy Volunteers
No
Conditions
Interventions
Abemaciclib
Administered orally
Temozolomide
Administered orally or IV
Locations (36)
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
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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Rome, 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. Ion Chiricuta
Cluj-Napoca, Romania
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain
Hospital Clinico San Carlos
Esplugues de Llobregat, Spain
Hospital Infantil Universitario Nino Jesus (HIUNJS)
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