Langerhans cell histiocytosis
Conditions
Interventions
Experimental group:Low-dose cytarabine combined with thalidomide
Sponsors
Langfang Campus of Chinese Academy of Medical Sciences Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Histopathology confirms a diagnosis of LCH; 2. Age between 18 and 70 years; 3. Multi-system involvement, or multiple lesions in a single system; 4. No previous systemic treatment (patients who only received local radiotherapy may be included); 5. ECOG performance status score <=2; 6. Clinician judges the patient suitable for treatment with this regimen; 7. The subject is able to understand the study protocol and is willing to participate, providing written informed consent;
Exclusion criteria
Exclusion criteria: 1. Patients with LCH involving the central nervous system; 2. Single-system, single-lesion LCH; 3. Major surgery within 4 weeks prior to the first dose in the study; 4. Radiotherapy within 4 weeks prior to the first dose in the study; 5. History of myocardial infarction within the past year; patients with New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, or a prior history of NYHA Class 3 or 4 congestive heart failure, unless the left ventricular ejection fraction (LVEF) is >=50% in an echocardiogram (ECHO) screening conducted within 1 month prior to entering the study; 6. Pregnant or breastfeeding women (women of childbearing potential testing positive for pregnancy at baseline or not having undergone a pregnancy test; postmenopausal women must have been menopausal for at least 12 months); 7. Abnormal liver or kidney function: creatinine levels >=176.8 µmol/L (2 mg/dl), transaminases or bilirubin levels greater than 2 times the upper limit of normal; 8. Severe hematologic abnormalities: absolute neutrophil count less than 1×10^9/L, platelets (PLT) less than 50×10^9/L; 9. Presence of uncontrolled infection; 10. Any other condition deemed by the investigator as rendering the patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR);Cytokine;FACT-G (Functional Assessment of Cancer Therapy-General);The sum of the proportions of subjects with the best overall response of complete remission (CR) or partial remission (PR).;circulating free DNA (cfDNA);Overall survival (OS); | — |
Countries
China
Contacts
Public ContactXinxin Cao
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed