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NCT02670707 · ClinicalTrials.gov registry record · Phase 3
Vinblastine/Prednisone Versus Single Therapy With Cytarabine for Langerhans Cell Histiocytosis (LCH)
A Phase 3 study of Langerhans Cell Histiocytosis, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 124
- Enrollment target
- 11
- Study locations
NCT02670707: Recruiting Phase 3 study of Langerhans Cell Histiocytosis, sponsored by Baylor College of Medicine.
NCT02670707 is a Phase 3 study of Langerhans Cell Histiocytosis that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 124 participants, below the 1,124-participant average among 8 other Langerhans Cell Histiocytosis trials with a reported enrollment target (89% lower). The trial reports 11 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02670707, a Phase 3 study of Langerhans Cell Histiocytosis, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 124 participants
- Enrollment target
- 11
- Study locations
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.
Primary Outcome
A Kaplan-Meier curve will be used to compare event-free survival between treatment groups. Curves will be compared using the log-rank statistic. Patients will be followed for up to 5 years after one year of therapy. Patients who have not had the event by the 5-year mark will be censored observations. Patients who are lost to follow-up without having an event will be censored at the time of last contact. Statistical significance will be assessed at the 0.05 level. A Cox proportional hazards mode
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 |
What NCT02670707 shows while recruiting
NCT02670707 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, below the 1,124-participant average among 8 other Langerhans Cell Histiocytosis trials with a reported enrollment target (89% lower).
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.
NCT02670707 lists 11 locations in 6 states (Texas, California, Minnesota).
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.
What interventions are being tested in trial NCT02670707?
The interventions under investigation include: Cytarabine (DRUG), Vinblastine/prednisone (DRUG).
Who is sponsoring clinical trial NCT02670707?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT02670707's enrollment target sits among peer trials
124 4th of 8 higher than 5 of 8 other Langerhans Cell Histiocytosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Langerhans Cell Histiocytosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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