Actively Recruiting
Vinblastine/Prednisone Versus Single Therapy With Cytarabine for Langerhans Cell Histiocytosis (LCH)
Led by Baylor College of Medicine · Updated on 2025-09-11
124
Participants Needed
11
Research Sites
669 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Vinblastine/Prednisone Versus Single Therapy With Cytarabine for Langerhans Cell Histiocytosis (LCH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Langerhans cell histiocytosis confirmed by biopsy
- Age between 0 and 21 years
- Karnofsky or Lansky performance score of 50% or higher
You will not qualify if you...
- Prior systemic chemotherapy for LCH or other cancers, except limited steroid use as defined
- Disease limited to a single skin or bone site, except certain CNS-risk or special site lesions
- Severe kidney disease (creatinine >3 times normal or clearance <50 ml/m2)
- Severe liver disease (direct bilirubin >3 mg/dl or AST >500 IU/L) unless caused by LCH
- Pregnancy or breastfeeding in female patients
- Patients unwilling to use birth control if of reproductive potential
- HIV positive patients
- Patients with lab abnormalities or low performance may be enrolled only with special approval
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Stanford Children's Hospital, Lucile Packard Children's Hospital
Palo Alto, California, United States, 94304
Actively Recruiting
2
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123
Actively Recruiting
3
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Withdrawn
4
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
5
Lehigh Valley Health Network- Cedar Crest
Allentown, Pennsylvania, United States, 18103
Actively Recruiting
6
Dell Children's Medical Center
Austin, Texas, United States, 78723
Actively Recruiting
7
Cook Children's Health Care System
Fort Worth, Texas, United States, 76104
Actively Recruiting
8
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
9
Vannie Cook Children's Clinic
McAllen, Texas, United States, 78503
Actively Recruiting
10
Children's Hospital of San Antonio
San Antonio, Texas, United States, 78207
Actively Recruiting
11
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States, 23507
Actively Recruiting
Research Team
O
Olive Eckstein, MD
CONTACT
C
Carl E. Allen, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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