A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy (I3Y-MC-JPEH)

Eli Lilly Japan K.K.0 个研究点目标入组 6 人开始时间: 2025年3月3日最近更新: 2025年6月2日

试验速览

阶段: 不适用
状态: 招募中
发起方: Eli Lilly Japan K.K.
入组人数: 6
主要终点: -

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomized Controlled Trial
干预模型: Parallel Assignment
主要目的: Treatment Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: No limit 至 21age old not（—）

入选标准

•Subjects required to meet all the folloiwng criteria.
•Biopsy proven high-grade glioma (HGG) as defined by 2016 World Health Organization (WHO) Classification Criteria, Grade 3-4 including:
•Anaplastic astrocytoma
•Anaplastic ganglioglioma
•Anaplastic oligodendroglioma.
•Anaplastic pleomorphic xanthoastrocytoma,
•Glioblastoma
•OR as defined by the 2021 WHO Classification Criteria as molecularly characterized:
•Non-pontine diffuse midline glioma, H3 K27-altered,
•Diffuse hemispheric glioma, H3 G34-mutant
•Diffuse pediatric HGG, H3/IDH-wildtype
•Isocitrate dehydrogenase-mutant (IDH-mutant) Infant-type hemispheric glioma
•High-grade astrocytoma with piloid features
•High-grade pleomorphic xanthoastrocytoma
•IDH-mutant diffuse glioma with homozygous cyclin- dependent kinase inhibitor 2A/B (CDKN2A/B) deletion,
•IDH-mutant and 1p/19q co-deleted oligodendroglioma
•IDH-mutant astrocytoma with homozygous CDKN2A/B deletion
•Patients who consent to use effective methods of contraception which meets the study criteria.
•Radiotherapy initiated within 6 weeks (+-1 week) of diagnosis and administered over 6 weeks (+-1 week). Participants <3 years of age, considered not suitable for radiotherapy may be eligible.
•Minimum of 4 weeks between completion of radiation and date of initial treatment (Cycle 1 Day 1 (C1D1)).
•Maximum of 8 weeks between completion of radiation and C1D
•Exceptional circumstances can be discussed with the medical monitor.
•Acute effects of prior therapies must be Grade <=1 unless deemed clinically insignificant by the investigator.
•Adequate hematologic and organ function <=7 days prior to C1D1
•Life expectancy of >=8 weeks and deemed likely to complete at least 1 cycle of treatment.
•A performance score of >=60 using:
•a) Lansky scale for participants <16 years
•b) Karnofsky scale for participants >=16 years
•Able to swallow and/or have a gastric/nasogastric tube.
•Any current systemic steroid use dose must be stable or decreasing at least 7 days prior to C1D
•Able and willing to adhere to study procedures, including frequent blood draws and MRI.
•At least 28 days since any major surgery, laparoscopic procedure, or a significant traumatic injury.
•Has a body surface area (BSA) of 0.2 m2 or over.
•Capable of giving sign on informed consent form or assent

排除标准

•Patients who meets any of the following criteria cannot participate in this clinical trial.
•Diffuse Intrinsic Pontine Glioma (DIPG) or diffuse midline glioma located in the ?
•Recurrent or refractory HGG including any recurrence/progression during/after radiotherapy.
•Secondary HGG, defined as a previously treated low-grade glioma that now meets high- grade criteria, or that resulted from a previously treated malignancy.
•Have known pathogenic somatic mutations appropriate for an anaplastic lymphoma kinase (ALK), B-rapidly accelerated fibrosarcoma (BRAF), or neurotrophic tyrosine receptor kinase (NTRK ) inhibitor, in regions where these therapies are available and deemed appropriate by the investigator.
•Prior HGG treatment (including bevacizumab), except for surgery and radiotherapy (with or without concomitant temozolomide)
•Current enrollment in another trial deemed.
•Treatment with an investigational product within the last 30 days or 5 half-lives (whichever is longer).
•Prior malignancy within the previous 3 years that, per the investigator and the medical monitor, may affect interpretation of study results.
•A preexisting medical condition(s) that, per the investigator, would preclude study participation.
•Any serious, active, systemic infection requiring IV antibiotic, antifungal, or antiviral therapy, including acute hepatitis B or C, or Human Immunodeficiency Virus at C1D
•Intolerability or hypersensitivity such as urticaria, anaphylaxis, toxic necrolysis, and/or Stevens-Johnson syndrome, to temozolomide, its excipients, or dacarbazine.
•Received a live virus vaccine within 28 days of C1D
•Pregnant, breastfeeding, or intend to become pregnant during the study.

结局指标

主要结局

Event Free Survival as determined by Blinded Independent Review Committee

次要结局

Event Free Survival

研究者

发起方

Eli Lilly Japan K.K.

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