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An Observational Cohort Study of Luvometinib in the Treatment of Langerhans Cell Histiocytosis and Histiocytic Neoplasms Based on [68Ga]Ga-FAPI PET/CT Examination

An Observational Cohort Study of Luvometinib in the Treatment of Langerhans Cell Histiocytosis and Histiocytic Neoplasms Based on [68Ga]Ga-FAPI PET/CT Examination

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600125932
Enrollment
Unknown
Registered
2026-06-01
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Langerhans Cell Histiocytosis

Interventions

Patients treated with Luvometinib for Langerhans cell histiocytosis (LCH) and histiocytic neoplasms:none

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

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

MeasureTime frame
ORR Based on the PRC Efficacy Evaluation Criteria;

Countries

China

Contacts

Public ContactYu Wu

West China Hospital, Sichuan University

wu_yu@scu.edu.cn+86 189 8060 1973

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026