Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 2
Eli Lilly and Company (Voir sur ClinicalTrials)
octobre 2024
février 2028
28 décembre 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | Contact (sur clinicalTrials) | ||||
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone - 13385 - Marseille - Bouches-du-Rhône - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Bordeaux Groupe Hospitalier Pellegrin Hopital des Enfants - 33076 - Bordeaux - Gironde - France | Contact (sur clinicalTrials) | ||||
| Centre Leon Berard - 69008 - Lyon - Rhône-Alpes - France | Contact (sur clinicalTrials) | ||||
| CHU de Nancy-Hopital de Brabois - 54500 - Vandoeuvre-les-Nancy - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion 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
- 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
- Contraceptive use should be consistent with local regulations for participants in
clinical studies.
- 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 Cycle 1 Day 1 (C1D1).
- Maximum of 8 weeks between completion of radiation and C1D1. 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:
1. Lansky scale for participants <16 years
2. 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 C1D1.
- 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.
- 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
- 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
- Contraceptive use should be consistent with local regulations for participants in
clinical studies.
- 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 Cycle 1 Day 1 (C1D1).
- Maximum of 8 weeks between completion of radiation and C1D1. 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:
1. Lansky scale for participants <16 years
2. 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 C1D1.
- 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.
Participants are excluded if any of the following apply:
- Diffuse Intrinsic Pontine Glioma (DIPG) or diffuse midline glioma located in the
pons.
- 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 incompatible with this study.
- 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 C1D1.
- Intolerability or hypersensitivity such as urticaria, anaphylaxis, toxic necrolysis,
and/or Stevens-Johnson syndrome to temozolomide, and/or abemaciclib, their
excipients, or dacarbazine.
- Received a live virus vaccine within 28 days of C1D1.
- Pregnant, breastfeeding, or intend to become pregnant during the study.