Clinical Trial

Response-adapted Luvometinib With or Without Cytarabine in Langerhans Cell Histiocytosis

Study acronym: LUCAS
Not Yet Recruiting Phase 2
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Summary
This single-center, prospective, interventional phase 2 study evaluates a response-adapted treatment strategy for patients aged 10 years and older with histologically confirmed Langerhans cell histiocytosis requiring systemic therapy. All participants receive six 35-day cycles of luvometinib induction. Post-induction treatment follows the cycle 6 PET/CT response: participants with complete metabolic response continue luvometinib maintenance without cytarabine, whereas participants without complete metabolic response who are judged suitable to continue protocol treatment receive luvometinib plus cytarabine followed by luvometinib maintenance; participants with progression or otherwise unsuitable to continue protocol treatment may receive other standard therapy or discontinue study treatment per protocol. The primary endpoint is objective response rate after six cycles by blinded independent central review.
Trial Details
NCT Number NCT07728201
Lead Sponsor Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Collaborators: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Conditions Langerhans Cell Histiocytosis
Enrollment 30 participants
Start Date 2026-06-30
Primary Completion 2028-07-31 (estimated)
Study Completion 2030-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-27