Efficacy and Safety of XTD Regimen (Selinexor, Thalidomide and Dexamethasone) in Adult Patients With Relapsed/Refractory LCH

NCT07204041 · tracked via the Priya Life Science China tracker

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Phase

Phase 2

Started

2025-08-01

Last updated

2025-10-02

Condition(s) studied

Langerhans Cell Histiocytosis (LCH)

Investigational drug(s) / intervention(s)

Selinexor →Thalidomide (100mg) →Dexamethasone →

Selinexor: The combined treatment period includes 12 cycles: receiving Selinexor (60mg, D1, 8, 15, 22), Thalidomide (100mg, D1-28), and Dexamethasone (40mg, D1, 8, 15, 22) as oral treatment, with each cycle lasting 28 days, for a total of 12 cycles of combined treatment, or until disease progression, death, or occurrence of intolerable toxicity. Alternatively, until disease progression, death, or occurrence of intolerable toxicity.

Thalidomide (100mg): The combined treatment period includes 12 cycles: receiving Selinexor (60mg, D1, 8, 15, 22), Thalidomide (100mg, D1-28), and Dexamethasone (40mg, D1, 8, 15, 22) as oral treatment, with each cycle lasting 28 days, for a total of 12 cycles of combined treatment, or until disease progression, death, or occurrence of intolerable toxicity. Alternatively, until disease progression, death, or occurrence of intolerable toxicity.

Dexamethasone: The combined treatment period includes 12 cycles: receiving Selinexor (60mg, D1, 8, 15, 22), Thalidomide (100mg, D1-28), and Dexamethasone (40mg, D1, 8, 15, 22) as oral treatment, with each cycle lasting 28 days, for a total of 12 cycles of combined treatment, or until disease progression, death, or occurrence of intolerable toxicity. Alternatively, until disease progression, death, or occurrence of intolerable toxicity.

Study summary

In adult patients with relapsed/refractory Langerhans cell histiocytosis (LCH), a treatment regimen of XTD regimen (Selinexor, Thalidomide and Dexamethasone) is planned to be used.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * Organ pathology confirmed diagnosis of LCH; * Age 18 years or older; * Multi-system involvement, or single system with multiple lesions; * Disease not relieved after receiving at least one systemic treatment, or disease relapsed after improvement; * ECOG performance status score ≤2; * Clinical physician determines suitability for this treatment protocol; * Subjects can understand the study protocol and are willing to participate in this study, providing written informed consent. Exclusion Criteria: * Single system single lesion LCH * Underwent major surgery within 4 weeks prior to the first administration of the study drug; * Underwent radiotherapy within 4 weeks prior to the first administration of the study drug; * History of myocardial infarction within the past year; suffers from New York Heart Association (NYHA) class 3 or 4 congestive heart failure, or has a history of NYHA class 3 or 4 congestive heart failure, unless left ventricular ejection fraction (LVEF) ≥ 50% in the echocardiogram (ECHO) screening performed within 1 month before entering the study; * Pregnant or breastfeeding women (women of childbearing age with positive pregnancy test at baseline or who have not undergone pregnancy testing. Postmenopausal women must have been menopausal for at least 12 months); * Abnormal liver and kidney function: creatinine level ≥176.8μmol/l (2mg/dl), transaminase and bilirubin levels more than 2 times the upper limit of normal (for LCH patients with liver involvement, transaminase levels more than 10 times and bilirubin levels more than 3 times the upper limit of normal); * Severe hematological abnormalities: absolute neutrophil count less than 1 × 10\^9/L, platelet less than 50×10\^9/L; * Presence of uncontrolled infections; * Any other circumstances that the investigator believes to be inappropriate for the patient to participate in this trial;

Primary outcome measure(s)

PFS — From enrollment to the end of treatment at 8 weeks
PFS defined as the time from XTD initiation to first documented disease progression, relapse after XTD, death from any cause, or last follow-up.

Trial sites (1)

Facility	City	Region	Status
Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, beijing,	Beijing	China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07204041 on ClinicalTrials.gov ↗ ← All trials in China