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

Comparing DAY101 with standard chemotherapy for kids with low-grade glioma.

Recruiting
25 years and younger
All
Phase 3

This study compares two treatments for children with low-grade glioma (LGG), a type of brain tumor. The study has two groups: one group gets **tovorafenib**, a new medicine, and the other gets standard chemotherapy, which is a common cancer treatment using strong drugs. The study will see which treatment works better, is safer, and easier to handle for the patients. About 400 patients will be part of this study.

To join, kids must be under 25 years old and have a specific change in their tumor called an RAF alteration. They also need to have a type of tumor called glioma or glioneuronal tumor, with at least one measurable tumor area.

The study will last until the tumor grows, or there are bad side effects, or if the patient decides to stop. Doctors will check the tumor's size using special guidelines called RANO criteria. The study is open to patients worldwide, and it’s important for the doctors to discuss any changes in symptoms with the study team.

  • Participants will be in the study until the tumor progresses, side effects occur, or they choose to stop.
  • Participants will receive either tovorafenib or a standard chemotherapy regimen.
  • Doctors must confirm tumor progression before changing treatment.
Study details
    Low-grade Glioma

NCT05566795

Day One Biopharmaceuticals, Inc.

9 February 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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