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Cobimetinib in Refractory Langerhans Cell Histiocytosis (LCH), and Other Histiocytic Disorders

Study acronym: NACHO-COBI
StatusRecruiting
PhasePhase 2
SponsorCarl Allen
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 18, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv16
  2. Primary completion date: Dec 2024 to Dec 2025
    • Study sites: 11 to 12
    • Eligibility criteria expanded, about 7 words
    v15
  3. Study sites: 9 to 11
    • Eligibility criteria revised
    • Study description revised
    v14
  4. Study sites: 8 to 9v13
  5. Eligibility criteria expanded, about 60 words
    • Site details revised at 1 of 8 sites
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. Study sites: 7 to 8v11
  2. Site details revised at 1 of 7 sitesv10
  3. Site details revised at 1 of 7 sitesv9
  4. Study sites: 4 to 7v8
  5. Study sites: 2 to 4v7
  6. Eligibility criteria expanded, about 35 wordsv6
  7. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 30, 2020 to Apr 19, 2021
    • Site details revised at 2 of 2 sites
    v5
  8. Start date: Jul 30, 2020 to Nov 30, 2020v4
  9. Start date: Mar 30, 2020 to Jul 30, 2020
    • Primary completion date: Aug 2024 to Dec 2024
    • Study completion date: Aug 2029 to Dec 2029
    • Eligibility criteria expanded, about 10 words
    v3
  10. Start date: Aug 30, 2019 to Mar 30, 2020v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Carl Allen
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This is a research study of a drug called cobimetinib in children and adults diagnosed with Langerhans cell histiocytosis (LCH), and other histiocytic disorders that has returned or does not respond to treatment. Cobimetinib blocks activation of a protein called Mitogen-activated protein kinase (MEK) that is part of incorrect growth signals in histiocytosis cells. Four different groups of patients will be enrolled.
Trial Details
NCT Number NCT04079179
Lead Sponsor Carl Allen
Collaborators: Baylor College of Medicine, North American Consortium for Histiocytosis, Genentech, Inc.
Conditions
(from sponsor)		 Langerhan's Cell Histiocytosis, Juvenile Xanthogranuloma, Erdheim-Chester Disease, Rosai Dorfman Disease, Neuro-Degenerative Disease, Histiocytic Sarcoma, Histiocytic Disorders, Malignant
Related terms Erdheim-Chester Disease, Histiocytic Disorders, Malignant, Histiocytic Sarcoma, Histiocytosis, Langerhans-Cell, Histiocytosis, Sinus, Xanthogranuloma, Juvenile
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov