Langerhans Cell Histiocytosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with treatment-naïve or relapsed/refractory Langerhans cell histiocytosis (LCH), Erdheim-Chester disease (ECD), or other histiocytic neoplasms. 2.Aged 18 years or older. 3.Patients with histologically confirmed LCH, ECD, or other histiocytic neoplasms. 4.Presence of at least one evaluable lesion based on PET Response Criteria (PRC). 5.ECOG performance status of 0 to 2. 6.Ability to understand and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1.Known allergy to the investigational drug, other MEK1/2 inhibitors, or any excipients. 2.Patients with dysphagia, active gastrointestinal diseases, malabsorption syndrome, or other conditions that may affect the administration or absorption of the investigational drug. 3.Pregnant or lactating women. 4.Any clinically significant condition that, in the investigator's judgment, would preclude participation in the study or compromise compliance with safety requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR Based on the PRC Efficacy Evaluation Criteria; | — |
Countries
China
Contacts
West China Hospital, Sichuan University