Response-adapted Luvometinib With or Without Cytarabine in Langerhans Cell Histiocytosis (NCT07728201) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Response-adapted Luvometinib With or Without Cytarabine in Langerhans Cell Histiocytosis
China30 participantsStarted 2026-06-30
Plain-language 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.
Who can participate
Age range
10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate after six cycles of luvometinib induction by blinded independent central review
Timeframe: At completion of six 35-day cycles, approximately week 30 / target C7D1 +/- 7 days
2
Incidence of adverse events and serious adverse events
Timeframe: Routine AE recording: consent to 30 days after last study treatment; TEAE summaries from first dose; SAEs, study-related AEs, pregnancy, and important safety information followed per protocol
Trial details
NCT IDNCT07728201
SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University