RECRUITING

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

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Conditions

Low-grade GliomaRapidly Accelerated Fibrosarcoma (RAF) Altered GliomaPediatric Low-grade GliomaRapidly accelerated fibrosarcomaRAF alteration gliomaGlioneural tumorOjemda

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a 2-arm, randomized, open-label, multicenter, global, Phase 3 trial to evaluate the efficacy, safety, and tolerability of tovorafenib monotherapy versus standard of care (SoC) chemotherapy in participants with pediatric low-grade glioma (LGG) harboring an activating rapidly accelerated fibrosarcoma (RAF) alteration requiring first-line systemic therapy.

Official Title

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

Quick Facts

Study Start:2023-02-27
Study Completion:2030-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05566795

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Less than 25 years of age with LGG with known activating RAF alteration.
  2. * Histopathologic diagnosis of glioma or glioneuronal tumor.
  3. * At least one measurable lesion as defined by RANO criteria.
  4. * Meet indication for first-line systemic therapy.
  1. * Participant has any of the following tumor-histological findings:
  2. 1. Schwannoma
  3. 2. Subependymal giant cell astrocytoma (Tuberous Sclerosis)
  4. 3. Diffuse intrinsic pontine glioma, even if histologically diagnosed as World Health Organization (WHO) Grade I-II
  5. * Participant's tumor has additional pathogenic molecular alterations, including but not limited to a) isocitrate dehydrogenase (IDH) 1/2 mutation, b) Histone H3 mutation, and c) neurofibromatosis Type 1 (NF-1) loss of function alteration.
  6. * Known or suspected diagnosis of NF-1/ neurofibromatosis Type 2 (NF-2).
  7. * Prior or ongoing nonsurgical anticancer therapy for this indication (eg, chemotherapy, oral/IV targeted therapy) including radiation.

Contacts and Locations

Study Contact

Day One Clinical Trials Information
CONTACT
650-484-0899
clinicaltrials@dayonebio.com

Study Locations (Sites)

Children's of Alabama
Birmingham, Alabama, 35233
United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027
United States
Children's Hospital of Orange County Main Campus - Orange
Orange, California, 92868
United States
UCSF Benioff Children's Hospital
San Francisco, California, 94158
United States
Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106-3322
United States
Children's National Medical Center
Washington, District of Columbia, 20010
United States
University of Florida Health
Gainesville, Florida, 32610
United States
Arnold Palmer Hospital for Children
Orlando, Florida, 32806
United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, 46202
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
University of Michigan - - C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109
United States
Children's Minnesota
Minneapolis, Minnesota, 55404
United States
St. Louis Children's Hospital
Saint Louis, Missouri, 63110
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-6878
United States
New York University Langone Health
New York, New York, 10016
United States
University of Rochester
Rochester, New York, 14642
United States
Duke Cancer Institute
Durham, North Carolina, 27705
United States
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
Texas Children's Hospital
Houston, Texas, 77030
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States
University of Wisconsin - Madison
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Day One Biopharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-27
Study Completion Date2030-03

Study Record Updates

Study Start Date2023-02-27
Study Completion Date2030-03

Terms related to this study

Keywords Provided by Researchers

  • Rapidly accelerated fibrosarcoma
  • RAF alteration glioma
  • Glioneural tumor
  • Ojemda

Additional Relevant MeSH Terms

  • Low-grade Glioma
  • Rapidly Accelerated Fibrosarcoma (RAF) Altered Glioma
  • Pediatric Low-grade Glioma