Actively Recruiting
Mirdametinib in Histiocytic Disorders
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-09-16
40
Participants Needed
1
Research Sites
368 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to see if treatment with mirdametinib in patients with Langerhans cell histiocytosis (LCH) or other histiocytic disorders will be better than current treatments and with fewer side effects.
CONDITIONS
Official Title
Mirdametinib in Histiocytic Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 2 years of age or older with a diagnosis of a histiocytic disorder requiring systemic therapy
- Diagnostic biopsy must be reviewed and confirmed by pathologist if available
- Tissue must be available for mutation testing if biopsy performed without prior molecular analysis
- Positive blood mutation test plus clinical features accepted if biopsy not feasible
- Measurable disease must be present on PET scan or brain MRI
- Adequate organ function including kidney, liver, and blood counts as defined by study thresholds
- Organ function abnormalities caused by histiocytic disease may be considered eligible
You will not qualify if you...
- Received cytotoxic chemotherapy affecting bone marrow within 14 days prior to enrollment
- Received MEK inhibitors or had disease progression on MEK inhibitors within 30 days prior to enrollment
- Use of systemic, inhaled, or ocular steroids within 14 days before first dose, except short-term use or physiologic steroids for endocrine deficiencies
- Received radiation therapy within 14 days prior to enrollment or to the orbit at any time
- Risk factors for retinal vein occlusion including high eye pressure, glaucoma, high cholesterol, triglycerides, hyperglycemia, or uncontrolled hypertension
- Left ventricular ejection fraction less than 55% or clinically significant heart disease unless caused by disease
- Pregnant or breastfeeding or unable to use acceptable birth control methods during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
M
Monica Trapp
CONTACT
C
Caitlin Cottrell
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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