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

LOGGIC/FIREFLY-2: A Phase 3, Randomized, International Multicenter Trial of DAY101 Monotherapy Versus Standard of Care Chemotherapy in Patients With Pediatric Low-Grade Glioma Harboring an Activating RAF Alteration Requiring First-Line Systemic Therapy

  • Clinical Trial Information

    Trial Contact: Parker, Melanie; Dubberly, Paige D; Doyle, Katherine M; Armatti, Julie M; Spinelli, Jennifer

  • IRB No: S22.264.12

    Protocol Abbrev: DAY101-002

    Principal Investigator:

    Phase: Drug: Phase III

    Age Group: Pediatric

    Secondary Protocol No: DAY101-002

    Treatment: Drug: DAY101; Drug: Chemotherapeutic Agent

    Therapies Involved: Monotherapy ID: NCT05566795

  • Objective

    evaluate the efficacy, safety, and tolerability of DAY101 monotherapy versus standard of care (SoC) chemotherapy in patients with pediatric low-grade glioma (LGG) harboring an activating rapidly accelerated fibrosarcoma (RAF) alteration requiring front-line systemic therapy.

  • Key Eligibility

    - 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