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Childhood and adolescent cancers
I3Y-MC-JPEH
A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy
- Open at Paris since : 05/12/2024
- Target : Child
- Phase : Phase II
Trial description
Primary Objective:;Evaluate the effectiveness of Abemaciclib in combination with Temozolomide compared to Temozolomide alone:;This typically includes measurements such as:;Overall Survival (OS): The duration of survival of participants from the start of treatment.;Progression-Free Survival (PFS): The length of time during which the disease does not progress.;Secondary Objectives:;Assess the safety and tolerability of the combined treatment:;Identify adverse effects associated with Abemaciclib in combination with Temozolomide.;Compare these side effects to those observed with Temozolomide alone.;Evaluate potential biomarkers:;Identify biological factors (such as genetic mutations or tumor markers) that may predict the response to treatment.;Analyze tumor response:;Assess tumor size reduction using imaging techniques (MRI or CT scans).;Measure the Objective Response Rate (ORR): The percentage of patients experiencing complete or partial tumor response.;Evaluate the impact on quality of life:;Use questionnaires to assess how the treatment affects participantsÀ physical, mental, and emotional well-being.
Url of the trialMain investigator
