DAY101 Vs. Standard of Care Chemotherapy in Pediatric Patients with Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  0 to 25

Participation Criteria

Inclusion Criteria:

* Less than 25 years of age with LGG with known activating RAF alteration
* Histopathologic diagnosis of glioma or glioneuronal tumor
* At least one measurable lesion as defined by RANO criteria
* Meet indication for first-line systemic therapy

Exclusion Criteria:

* Patient has any of the following tumor-histological findings:

1. Schwannoma
2. Subependymal giant cell astrocytoma (Tuberous Sclerosis)
3. Diffuse intrinsic pontine glioma, even if histologically diagnosed as World Health Organization (WHO) Grade I-II
* Patient's tumor has additional pathogenic molecular alterations, including but not limited to a) IDH 1/2 mutation, b) Histone H3 mutation, and c) NF-1 loss of function alteration.
* Known or suspected diagnosis of neurofibromatosis Type 1 or 2 (NF-1/NF-2)
* Prior or ongoing nonsurgical anticancer therapy for this indication (eg, chemotherapy, oral/intravenous targeted therapy) including radiation