I3Y-MC-JPEH - A randomzed phase 2 study evaluating Abemaciclib in combination with Temozolomide vs Temozolomide monotherapy in children and young adults with newly diagnosed HGG (High Grade Glioma) following radiotherapy.

Studio Clinico

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

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2022-502269-13-00

Data di inserimento: 16.12.2024

Promotore

Eli Lilly and Company

Principal Investigator ITALIA

Riferimento: Dr. - -

Telefono: 00000

Email: nd@nd.it

Localita: -