Response-adapted Luvometinib With or Without Cytarabine in Langerhans Cell Histiocytosis | NCT07728201

NCT07728201

Overview

NCT ID: NCT07728201
Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityOTHER
Official Title: Luvometinib Monotherapy or Combined With Cytarabine for Langerhans Cell Histiocytosis: A Response-adapted, Interventional, Prospective Study
Brief 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 27, 2026Actual
Start Date: Jun 30, 2026Estimated
Primary Completion Date: Jul 31, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Phase 2
Enrollment: 30Estimated
Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Sequential Assignment
Masking: Single

Contacts and Locations

Central Contacts: Qi ZhuContact
zhuqi70@hotmail.com0086-18116215629

Similar Studies

Participant Group/Arms

A: CMR response pathExperimental

All participants receive luvometinib induction for six 35-day cycles before response assessment. Participants achieving complete metabolic response after induction continue luvometinib maintenance without cytarabine for 18 additional 35-day cycles unless progression, unacceptable toxicity, death, or withdrawal occurs. If confirmed progression occurs during maintenance, participants may transition to combination treatment, receive other standard salvage therapy, or discontinue study treatment; progression is counted as a PFS event and, if the participant previously achieved CMR or PMR, a DOR event. Follow-up continues unless follow-up consent is withdrawn.

Drug: Luvometinib

B: Non-CMR response pathExperimental

All participants receive luvometinib induction for six 35-day cycles before response assessment. Participants not achieving complete metabolic response and judged suitable to continue protocol treatment receive luvometinib plus cytarabine for 12 35-day cycles, followed by luvometinib maintenance for 6 additional 35-day cycles.

Drug: Luvometinib, Cytarabine.