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

Starting soon · Phase 2

Conditions studied: Langerhans Cell Histiocytosis

In brief

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.

Key facts

Study ID

NCT07728201

Run by

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

People needed

30

Starts

2026-06-30

Expected to finish

2030-06-30

Last updated by the study team

2026-07-27

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed Langerhans cell histiocytosis (LCH).
• Age 10 years or older.
• Systemic treatment indication and at least one PET response criteria-evaluable lesion.
• Expected survival of at least 12 weeks, as judged by the investigator, and able to undergo protocol-specified treatment, assessments, and follow-up.
• ECOG performance status 0-2 or Lansky score >=60.
• Adequate organ function as defined in the protocol.
• Written informed consent from adult participants or legal guardians, with participant assent when applicable.

You may not qualify if…

• Hypersensitivity to luvometinib or any excipient.
• Concurrent other malignant tumor.
• Pregnancy or breastfeeding.
• Failure to meet protocol contraception requirements.
• Active bacterial, fungal, or viral infection.
• Significant retinal disease or glaucoma.
• NYHA class >=3 heart failure or LVEF <50%.
• Psychiatric disease or other condition preventing protocol compliance.
• Investigator judgment that participation is unsuitable.

Where it is running

• Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China

Full record on ClinicalTrials.gov

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