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Vinblastine/Prednisone Versus Single Therapy With Cytarabine for Langerhans Cell Histiocytosis (LCH)
NCT02670707 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Cytarabine
- DRUG Vinblastine/prednisone
Study Locations (11)
Texas
- Dell Children's Medical Center — Austin
- Cook Children's Health Care System — Fort Worth
- Texas Children's Hospital — Houston
- Vannie Cook Children's Clinic — McAllen
- Children's Hospital of San Antonio — San Antonio
California
- Stanford Children's Hospital, Lucile Packard Children's Hospital — Palo Alto
- Rady Children's Hospital - San Diego — San Diego
Minnesota
- University of Minnesota/Masonic Cancer Center — Minneapolis
Ohio
- Nationwide Children's Hospital — Columbus
Pennsylvania
- Lehigh Valley Health Network- Cedar Crest — Allentown
Virginia
- Children's Hospital of The King's Daughters — Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2016-03-07 |
| Est. Completion | 2029-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02670707
The ClinicalTrials.gov registry entry for NCT02670707 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 678 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Langerhans Cell Histiocytosis appearing as the primary indexed condition, and to 2 interventions — of which Cytarabine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02670707 reports 11 study locations spanning 6 distinct geographic areas — top geographies include Texas, California, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02670707 about?
NCT02670707 is a clinical study titled "Vinblastine/Prednisone Versus Single Therapy With Cytarabine for Langerhans Cell Histiocytosis (LCH)". 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 (change...
What is the current status of trial NCT02670707?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 124 participants. The study started on 2016-03-07. Estimated completion is 2029-01.
What conditions does trial NCT02670707 study?
This clinical trial studies the following conditions: Langerhans Cell Histiocytosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02670707?
The interventions under investigation include: Cytarabine (DRUG), Vinblastine/prednisone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02670707?
This trial is sponsored by Baylor College of Medicine, which has 678 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02670707 being conducted?
This trial has 11 study locations across California, Minnesota, Ohio, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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