Vinblastine/Prednisone Versus Single Therapy With Cytarabine for Langerhans Cell Histiocytosis (LCH)
Public ClinicalTrials.gov record NCT02670707. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomization of Cytarabine Monotherapy Versus Standard-of-Care Vinblastine/Prednisone for Frontline Treatment of Langerhans Cell Histiocytosis (TXCH LCH0115)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02670707
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 124 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Up to 21 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 6, 2016
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2028
- Last update posted
- Sep 10, 2025
2016 – 2029
United States locations
- U.S. sites
- 11
- U.S. states
- 6
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford Children's Hospital, Lucile Packard Children's Hospital | Palo Alto | California | 94304 | Recruiting |
| Rady Children's Hospital - San Diego | San Diego | California | 92123 | Recruiting |
| University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | 55455 | Withdrawn |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | Recruiting |
| Lehigh Valley Health Network- Cedar Crest | Allentown | Pennsylvania | 18103 | Recruiting |
| Dell Children's Medical Center | Austin | Texas | 78723 | Recruiting |
| Cook Children's Health Care System | Fort Worth | Texas | 76104 | Recruiting |
| Texas Children's Hospital | Houston | Texas | 77030 | Recruiting |
| Vannie Cook Children's Clinic | McAllen | Texas | 78503 | Recruiting |
| Children's Hospital of San Antonio | San Antonio | Texas | 78207 | Recruiting |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02670707, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 10, 2025 · Synced Sep 19, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02670707 live on ClinicalTrials.gov.