A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy (NCT06413706)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Children's Hospital of Orange County - Orange โ Orange, California
Age range: 0 Years to 20 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (37 Sites)
Showing the first 25 of 37 sites.
- Children's Hospital of Orange County - Orange โ Orange, California
- Lucile Packard Children's Hospital (LPCH) - Stanford University โ Palo Alto, California
- Riley Hospital for Children at Indiana University Health โ Indianapolis, Indiana
- The Johns Hopkins Hospital (JHH) - Johns Hopkins Childrens Center โ Baltimore, Maryland
- University of Michigan Health System (UMHS) - C.S. Mott Children's Hospital - Hematology Oncology Clinic โ Ann Arbor, Michigan
- Mayo Clinic โ Rochester, Minnesota
- Rhode Island Hospital โ Providence, Rhode Island
- UT Southwestern Medical Center Dallas/Childrens Medical Center โ Dallas, Texas
- The University of Texas MD Anderson Cancer Center โ Houston, Texas
- Queensland Government- Lady Cilento Children's Hospital โ Brisbane,
- Perth Children's Hospital โ Nedlands,
- The Children's Hospital at Westmead โ Westmead,
- Universitair Ziekenhuis Gent (Uz Gent) โ Ghent,
- Universitair Ziekenhuis Leuven โ Leuven,
- Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc โ Woluwe-Saint-Lambert,
- Copenhagen University Hospital-Rigshospitalet University Hospital โ Copenhagen,
- Centre Hospitalier Universitaire de Bordeaux Groupe Hospitalier Pellegrin Hopital des Enfants โ Bordeaux,
- Centre de Lutte Contre le Cancer (CLCC) - Centre Oscar Lambret โ Lille,
- Centre Leon Berard โ Lyon,
- Hopital La Timone โ Marseille,
- Institut Curie โ Paris,
- Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP โ Villejuif,
- Fondazione IRCCS Istituto Nazionale dei Tumori โ Milan,
- Azienda Ospedaliera Di Rilievo Nazionale Santobono Pausilipon โ Naples,
- IRCCS Ospedale Pediatrico Bambino Gesu โ Rome,
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Glioma
- Abemaciclib Neuropharmacokinetics of Diffuse Midline Glioma Using Intratumoral Microdialysis โ Bethesda, Maryland
- Pembrolizumab (MK-3475) in Patients With Recurrent Malignant Glioma With a Hypermutator Phenotype โ Los Angeles, California
- Cognitive Changes of IDH-mutant and IDH-wildtype Glioma Patients After Chemoradiotherapy With Radiation Dose to the Resting State Networks โ St Louis, Missouri
- Simultaneous Multinuclear Metabolic MRI in Newly Diagnosed or Recurrent Glioma โ Los Angeles, California
- Simulation-Based Caregiving Skills Training for Family Members of High Grade Glioma Patients โ Houston, Texas
- ExAblate (Magnetic Resonance-guided Focused Ultrasound Surgery) Treatment of Brain Tumors โ Toronto, Ontario
Explore by condition: All Glioma clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.