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A Phase II Trial of the MEK Inhibitor Mirdametinib in Histiocytic Disorders
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.
Details
| Lead sponsor | Children's Hospital Medical Center, Cincinnati |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 40 |
| Start date | 2024-02-05 |
| Completion | 2031-03 |
Conditions
- Langerhans Cell Histiocytosis (LCH)
- Juvenile Xanthogranuloma (JXG)
- Rosai-Dorfman Disease (RDD)
- Histiocytic Disorders
Interventions
- Mirdametinib
Primary outcomes
- Response rate to mirdametinib — 1 year (completion of 13 four week cycles)
Best overall response rate to mirdametinib after 13 four-week cycles as defined by positron emission tomography (PET) or magnetic resonance imaging (MRI) (for isolated pituitary/central nervous system (CNS) disease) response criteria.
Countries
United States