Langerhans cell histiocytosis in adults
Conditions
Interventions
Trial group:Luvometinib:Dosages: 1.0 mg/tablet and 4.0 mg/tablet. At the start of the study, you will continue to take the current dose, as a single oral dose once daily, on a continuous basis, with e
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients in the FCN-159-005 study’s mIIT analysis set; 2. Patients whom researchers believe will continue to benefit from ongoing treatment. 3. Willing to continue participating in a long-term follow-up study, able to understand and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Conditions that researchers believe would interfere with participation in the study or prevent compliance with safety requirements. 2. Patients who are unable to comply with visit-related requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Disease Control Rate (DCR);Clinical Benefit Rate (CBR);Duration of Relief ( DOR);Overall survival (OS);Safety endpoints: Assessment of the frequency and severity of adverse events, serious adverse events, deaths and abnormal safety findings (e.g. laboratory tests, vital signs, physical examination, electrocardiogram, ECOG, etc.) in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0; the proportion of patients who required dose adjustment or discontinuation of treatment due to drug toxicity.;Changes in the EORTC-QLQ-C30 (Version 3.0) Quality of Life (QOL) questionnaire; | — |
Countries
China
Contacts
Public ContactLi Jian
Peking Union Medical College Hospital
Outcome results
None listed