A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young… (NCT06413706) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy
United States, Australia, Belgium45 participantsStarted 2024-10-25
Plain-language 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.
Who can participate
Age range
0 Years – 20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Lansky scale for participants \<16 years
. Karnofsky scale for participants ≥16 years
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Phase 2 and is comparing abemaciclib plus temozolomide against temozolomide alone in children and young adults with high-grade glioma — what does the Phase 2 status mean for how much is already known about the safety and benefit of adding abemaciclib to temozolomide?
2The trial is no longer actively recruiting new participants — does that mean enrollment is closed, and if so, are there similar or follow-up studies that might be worth considering for our situation?
3The main outcome being measured is 'event free survival,' which likely includes tumor progression or recurrence — can you help me understand what that means in practice, and how the two treatment approaches in this trial compare to what would typically be recommended after radiotherapy?
4Since this trial is specifically for children and young adults after radiotherapy, how does my child's or young adult's age, tumor type, and treatment history fit with what this study was designed to evaluate, and would standard care be a stronger first step?
5What are the known side effects of combining abemaciclib with temozolomide in this age group, and are there any added risks compared to temozolomide alone that we should weigh carefully before considering this kind of treatment approach?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Event Free Survival as Determined by Blinded Independent Review Committee