Patologia: Neoplasie cerebrali
Osservazionale-Sperimentale: Sperimentale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: Sì
Fase di studio: II Randomizzato
Linee di trattamento: Prima linea
Criteri di inclusione:
- Newly diagnosed, biopsy proven*, WHO grade III or IV high-grade glioma (based on local pathology report). High grade classification may be defined by integration of histology, immunohistochemistry, and/or methylation profile, and/or molecular characterization and include:
a. Anaplastic astrocytoma
b. Glioblastoma
c. Anaplastic pleomorphic xanthoastrocytoma
d. Anaplastic ganglioglioma
e. Anaplastic oligodendroglioma
f. High-grade astrocytoma with piloid features
g. Pediatric-type diffuse HGG (including diffuse intrinsic pontine glioma [DIPG])
i. Diffuse midline glioma, H3 K27-altered
ii. Diffuse hemispheric glioma, H3 G34-mutant
iii. Diffuse pediatric-type HGG, H3-wildtype and IDH-wildtype
iv. Infant-type hemispheric glioma
- Less than 21 years of age at time of enrollment
Note to CDCs: at least 22 patients must be <18 years, so please prioritize pediatric sites
- At least one measurable lesion for participants with pontine DMG or DIPG per RAPNO DIPG criteria (Cooney et al. 2020)
- Initiated radiation according to local standards within 6 weeks (±1 week ) of diagnosis and administered over 6 weeks (±1 week)
- Concomitant temozolomide allowed but not required. A temozolomide washout (minimum of 4 weeks) is required before C1D1.
- Able to start C1D1 within 4-8 weeks for HGG or 4-6 weeks for DIPG after radiotherapy completion
- Lansky/Karnofsky performance score ≥60
- Must be able to swallow or have NG/G tube
- If currently on systemic steroids, dose must be stable or decreasing dose at least 7 days prior to C1D1
- Able and willing to adhere to the treatment and procedures, including frequent blood draws and MRIs.
Criteri di esclusione:
- Recurrent or refractory HGG that progressed or recurred during/after initial radiotherapy
- Secondary HGG, defined as a previously treated low-grade glioma that now meets high-grade glioma classification criteria, or that resulted from any other previously treated malignancy
- Have known pathogenic somatic mutations appropriate for a BRAF or NTRK inhibitor, in regions where these therapies are approved and available, per investigator’s discretion
- Prior treatment for HGG, including bevacizumab, with the exception of surgery, radiotherapy, and temozolomide
- Additional malignancy within 3 years prior to enrollment that may affect the interpretation of results
- Pre-existing medical condition or active infection that would preclude participation in this study
- Intolerability or hypersensitivity to any of the study treatments
- Live virus vaccine with in 28 days of C1D1
- Pregnant, breastfeeding, or intend to become pregnant during the study.
Trattamento sperimentale:
Abemaciclib
Trattamento di controllo:
Temozolomide
IRCCS Istituto Giannina Gaslini
Largo G. Gaslini 5 - 16148 Genova - GE
Neuro-Oncologia
IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI
S.C. Pediatria Oncologica
Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD
UOC Oncologia 1 - NB: Arruolamento pazienti non ancora attivo
AOU Città della Salute e della Scienza di Torino
Corso Bramante 88 - 10126 Torino - TO
Oncoematologia Pediatrica - NB: Arruolamento pazienti non ancora attivo
Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM
Oncologia Pediatrica - NB: Arruolamento pazienti non ancora attivo
Ospedale Pediatrico Bambin Gesù
Piazza Sant Onofrio 4 - 00165 Roma - RM
UO Neuro-Oncologia
AORN Santobono-Pausilipon
Via Della Croce Rossa 8 - 80122 Napoli - NA
Numero di iscrizione a registro: 2022-502269-13-00
Data di inserimento: 16.12.2024
Eli Lilly and Company
Riferimento: Dr. - -
Telefono: 00000
Email: nd@nd.it
Localita: -