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Clinical trialNCT02670707RecruitingPhase 3Interventional

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

SponsorBaylor College of MedicineEnrollment124Langerhans Cell Histiocytosis
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

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Sites

11 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Stanford Children'S Hospital, Lucile Packard Children'S Hospital

    Palo Alto, California, United States

    Recruiting
  • Rady Children'S Hospital - San Diego

    San Diego, California, United States

    Jennifer Yu, MD
    Recruiting
  • University of Minnesota/masonic Cancer Center

    Minneapolis, Minnesota, United States

    Withdrawn
  • Nationwide Children'S Hospital

    Columbus, Ohio, United States

    Recruiting
  • Lehigh Valley Health Network- Cedar Crest

    Allentown, Pennsylvania, United States

    Recruiting
  • Dell Children'S Medical Center

    Austin, Texas, United States

    Virgina Harrod, MD, PhD
    Recruiting
  • Cook Children'S Health Care System

    Fort Worth, Texas, United States

    Recruiting
  • Texas Children'S Hospital

    Houston, Texas, United States

    Recruiting
  • Vannie Cook Children'S Clinic

    McAllen, Texas, United States

    Recruiting
  • Children'S Hospital of San Antonio

    San Antonio, Texas, United States

    Timothy Griffin, MD
    Recruiting
  • Children'S Hospital of the King'S Daughters

    Norfolk, Virginia, United States

    William Owen, MD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Cytarabine →Vinblastine
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
7 Mar 2016
Primary completion
31 Jan 2027
Completion
31 Jan 2029
Last update posted
11 Sept 2025
Registered enrollment
124
Registry id
NCT02670707

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.