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A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histiocytosis

Exploring Tovorafenib for Langerhans Cell Histiocytosis progression or relapse.

Recruiting
180-22 years
All
Phase 2

This study looks at how a new drug, tovorafenib (DAY101), can help people with a disease called Langerhans Cell Histiocytosis (LCH). LCH happens when too many immature white blood cells called Langerhans cells build up and form tumors. These tumors can damage bones, skin, and other organs. The study is for people whose LCH is getting worse or hasn't responded well to other treatments.

Participants will take tovorafenib by mouth once a week for about a year. Researchers want to see how well the drug works and what side effects it might cause. They will also check how the disease changes with treatment. To be eligible, you must be under 22, have a body surface area of at least 0.3 m², and meet other health criteria.

  • The study lasts for up to a year with visits every month.
  • Participants will have regular scans and blood tests.
  • There may be risks like side effects from the drug.

After the study, there will be follow-ups for up to two years to monitor health changes.

Study details
    Recurrent Langerhans Cell Histiocytosis
    Refractory Langerhans Cell Histiocytosis

NCT05828069

National Cancer Institute (NCI)

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