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Vinblastine/Prednisone Versus Single Therapy With Cytarabine for Langerhans Cell Histiocytosis (LCH)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jan 2025 to Jan 2027 Site contacts updated at 4 of 11 sitesv16 Show 1 more changeShow less
    • Site contacts updated at 4 of 11 sites
  2. Study description expanded, about 9 words Site contacts updated at 1 of 11 sitesv15 Show 1 more changeShow less
    • Site contacts updated at 1 of 11 sites

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 2 of 11 sitesv14
  4. Primary completion date: Jan 2023 to Jan 2025 Completion date: Jan 2027 to Jan 2029v13 Show 1 more changeShow less
    • Completion date: Jan 2027 to Jan 2029
  5. Study sites: 5 to 11v12
Show 10 earlier versionsHide 10 earlier versions
  1. Study sites: 3 to 5v11
  2. Secondary endpoints: 7 to 8v10 See this version in full on ClinicalTrials.gov ↗
  3. Eligibility criteria expanded, about 112 wordsv9 See this version in full on ClinicalTrials.gov ↗
  4. Study sites: 1 to 3v8
  5. Primary completion date: Jan 2021 to Jan 2023 Completion date: Jan 2025 to Jan 2027v7 Show 1 more changeShow less
    • Completion date: Jan 2025 to Jan 2027
  6. Start date: Mar 2016 to Mar 7, 2016 Eligibility criteria expanded, about 11 words · Secondary endpoints expanded, about 130 words · Study description expanded, about 7 words · 1 morev6 Show 4 more changesShow less
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints expanded, about 130 words
    • Study description expanded, about 7 words
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  7. 2 versions Re-verified since Jul 12, 2017, no change to tracked fieldsv4-v5
  8. Completion date: Jan 2025v3
  9. Trial status: Not Yet Recruiting to Recruiting Start date: Jan 2016 to Mar 2016 · Site details revised · Study description expanded, about 1 wordv2 Show 3 more changesShow less
    • Start date: Jan 2016 to Mar 2016
    • Site details revised
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Langerhans Cell Histiocytosis (LCH) is a type of cancer that can damage tissue or cause lesions to form in one or more places in the body. Langerhans cell histiocytosis (LCH) is a cancer that begins in LCH cells (a type of dendritic cell which fights infection). Sometimes there are mutations (changes) in LCH cells as they form. These include mutations of the BRAF gene. These changes may make the LCH cells grow and multiply quickly. This causes LCH cells to build up in certain parts of the body, where they can damage tissue or form lesions. For most patients with LCH, standard-of-care vinblastine/prednisone are used as front-line therapy while cytarabine therapy has been used as therapy for patients who develop recurrence. No alternate treatment strategy has been developed for frontline therapy in LCH. The purpose of this research study is to compare previously used vinblastine/prednisone to single therapy with cytarabine for LCH. We will evaluate the utility of an imaging study called a positron emission tomography (PET) scan to more accurately assess areas of LCH involvement not otherwise seen in other imaging studies as well as response to therapy. We also want to identify if genetic and other biomarkers (special proteins in patient's blood and in patient's cancer) relate to the response of patients LCH to study treatment.
Trial Details
NCT Number NCT02670707
Lead Sponsor Baylor College of Medicine
Conditions Langerhans Cell Histiocytosis
Enrollment 124 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov