DAY101 vs. Standard of Care Chemotherapy in Pediatric Patients With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)
Purpose
This is a 2-arm, randomized, open-label, multicenter, global, Phase 3 trial to 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.
Condition
- Low-grade Glioma
Eligibility
- Eligible Ages
- Under 25 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 activating molecular alterations - 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- DAY101 versus standard of care chemotherapy
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm #1 |
DAY101 |
|
|
Active Comparator Arm #2 |
Investigator's choice of one of the following current standard of care for pediatric patients with low-grade gliomas: Children's Oncology Group - Vincristine/Carboplatin (COG-V/C) International Society for Paediatric Oncology - Low-Grade Glioma Vincristine/Carboplatin (SIOPe-LGG-V/C) Vinblastine (VBL) |
|
Recruiting Locations
Children's National and nearby locations
Washington, District of Columbia 20010
More Details
- NCT ID
- NCT05566795
- Status
- Recruiting
- Sponsor
- Day One Biopharmaceuticals, Inc.
Detailed Description
Approximately 400 treatment-naïve low-grade glioma patients will be randomized 1:1 to either DAY101 (Arm 1) or an Investigator's choice of SoC chemotherapy (Arm 2). Arm 1 (DAY101): treatment cycles will repeat every 28 days in the absence of disease progression. Patients will continue DAY101 until any of the following occurs: radiographic progression based on Response Assessment in Neuro-Oncology (RANO) criteria as determined by the Investigator and confirmed by the Independent Review Committee (IRC), unacceptable toxicity, withdrawal of consent to treatment, or end of study. Arm 2 (Investigator's Choice of SoC Chemotherapy): patients will receive one of 3 SoC chemotherapy options selected by the treating Investigator: Children's Oncology Group - Vincristine/Carboplatin (COG-V/C) regimen, International Society for Paediatric Oncology - Low-Grade Glioma Vincristine/Carboplatin (SIOPe-LGG-V/C) regimen, or vinblastine (VBL) regimen. The choice of SoC chemotherapy regimen will be selected prior to patient randomization. Treatment will continue until completion of therapy or until any of the following occurs: radiographic progression based on RANO criteria as determined by the Investigator and confirmed by the IRC, unacceptable toxicity, withdrawal of consent to treatment, or end of study. During treatment phase, patients who demonstrate radiographic progression per RANO criteria as determined by the Investigator and confirmed by IRC in Arm 1 (DAY101) may be allowed to continue DAY101 if, in the opinion of the Investigator, the patient is deriving clinical benefit from continuing study treatment and approved by the Sponsor. Patients who demonstrate radiographic progression per RANO criteria as determined by the Investigator and confirmed by IRC during the treatment phase in Arm 2 (SoC chemotherapy) and discontinue treatment may be eligible to receive DAY101 at the same treatment and assessment schedule. In addition, Arm 2 patients who demonstrate radiographic progression after completion of chemotherapy [ie, during long-term follow-up (LTFU)] may be eligible to receive DAY101.