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Mirdametinib in Histiocytic Disorders

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: Children's Hospital Medical Center, Cincinnati to Children's Hospital Medical Center, Cincinnati Eligibility criteria expanded, about 24 words · Secondary endpoints: details revised at 4 of 4 entries · Site details revised Show 3 more changesShow less
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Site details revised
  2. Eligibility criteria shortened, about 987 words Secondary endpoints: 8 to 4v9 Show 1 more changeShow less
    • Secondary endpoints: 8 to 4

    See this version in full on ClinicalTrials.gov ↗

  3. Eligibility criteria expanded, about 57 wordsv8 See this version in full on ClinicalTrials.gov ↗
  4. Site contact updatedv7
  5. Site contact updatedv6
Show 4 earlier versionsHide 4 earlier versions
  1. Enrollment target: 50 to 40 Eligibility criteria expanded, about 259 wordsv5 Show 1 more changeShow less
    • Eligibility criteria expanded, about 259 words

    See this version in full on ClinicalTrials.gov ↗

  2. Start date changed from estimate of Mar 2024 to Feb 5, 2024v4
  3. Start date: Dec 2023 to Mar 2024 Primary completion date: Dec 2029 to Mar 2030 · Completion date: Dec 2030 to Mar 2031v3 Show 2 more changesShow less
    • Primary completion date: Dec 2029 to Mar 2030
    • Completion date: Dec 2030 to Mar 2031
  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to see if treatment with mirdametinib in patients with Langerhans cell histiocytosis (LCH) or other histiocytic disorders will be better than current treatments and with fewer side effects.
Trial Details
NCT Number NCT06153173
Lead Sponsor Children's Hospital Medical Center, Cincinnati
Conditions Langerhans Cell Histiocytosis (LCH), Juvenile Xanthogranuloma (JXG), Rosai-Dorfman Disease (RDD), Histiocytic Disorders
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov