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ACTIVE NOT RECRUITING
NCT06413706
PHASE2

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

View on ClinicalTrials.gov

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

DRUG

Abemaciclib

Administered orally

DRUG

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