Mirdametinib in Histiocytic Disorders

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT06153173
Phase
PHASE2
Status
Recruiting
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Conditions

  • Histiocytic Disorders
  • Juvenile Xanthogranuloma (JXG)
  • Langerhans Cell Histiocytosis (LCH)
  • Rosai-Dorfman Disease (RDD)

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mirdametinib — DRUG
    Mirdametinib is administered by mouth twice daily on a continuous schedule, with each cycle being 4 weeks. Patients are instructed to take consecutive doses separated by a minimum of 6 hours and a maximum of 14 hours.

Study Details

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.

Key Dates

Start date
Feb 5, 2024
Status verified
Sep 2025
Primary completion
Mar 31, 2030
Completion
Mar 31, 2031

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Mirdametinib
    Mirdametinib will be dosed by mouth twice a day at a dose of 2 mg/m2 BID with a max of 4 mg BID (8 mg per day max).

Primary Outcome Measure

Response rate to mirdametinib [ Time Frame: 1 year (completion of 13 four week cycles) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Monica Trapp
[email protected]
Caitlin Cottrell
[email protected]
Ashish Kumar, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Cincinnati Children's Hospital Medical Center· Cincinnati, OH

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