Clin2
NCT05828069Possibly a fitRecruiting

Tovorafenib for young people with worsening Langerhans cell histiocytosis

Recurrent Langerhans Cell HistiocytosisRefractory Langerhans Cell Histiocytosis

Treatments studied

Part of Blood & lymphatic, Lungs & breathing clinical trials.

This Phase 2 trial tests tovorafenib (DAY101) to treat children and young people whose Langerhans cell histiocytosis (LCH) is getting worse, came back, or did not respond to prior treatment. It may help by targeting certain gene changes found in the LCH.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2
Enrollment
48 people
Ages
6 months to 22 years
Study type
Interventional

Who can take part

  • Your age must be between 180 days old and under 22 years when you enroll.
  • You must have LCH that can be measured on scans, and it must be progressing, relapsing, or refractory after prior systemic treatment.
  • Your diagnosis must be confirmed with tissue pathology showing LCH, and the team will need submitted biopsy/tissue samples for confirmation and gene testing.
  • Your tumor must have a specific gene mutation (not just a test that suggests it): CSFR1, ERBB3, or ALK, or RAS/RAF mutations.
  • You must be able to take the study medicine by mouth or through a feeding tube, and your blood counts and organ tests must meet safety thresholds.
  • You must not have had certain recent treatments (most cancer drugs/clinical trials within 14 days, radiation within 2 weeks) and must not have certain medical conditions (like severe infections or some eye/heart risks).

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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