Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase
Phase 2
Started
2025-04-12
Last updated
2025-09-22
Condition(s) studied
Langerhans Cell Histiocytosis
Investigational drug(s) / intervention(s)
Cytarabine (Ara-C)Thalidomide (100mg)
Cytarabine (Ara-C): The treatment regimen consists of Ara-C administered at a dose of 100 mg/m² from days 1 to 5, combined with thalidomide at a dose of 100 mg from days 1 to 35, repeated every 35 days for a total of 12 cycles. Following this, thalidomide will be given as monotherapy at a dose of 100 mg from days 1 to 28, administered every 28 days for an additional 12 cycles of maintenance treatment. In total, participants will undergo 24 cycles of treatment.
Thalidomide (100mg): The treatment regimen consists of AraC administered at a dose of 100 mg/m² from days 1 to 5, combined with thalidomide at a dose of 100 mg from days 1 to 35, repeated every 35 days for a total of 12 cycles. Following this, thalidomide will be given as monotherapy at a dose of 100 mg from days 1 to 28, administered every 28 days for an additional 12 cycles of maintenance treatment. In total, participants will undergo 24 cycles of treatment.
Study summary
Treatment of Adult Patients with Newly Diagnosed Langerhans Cell Histiocytosis (LCH) Using a Low-Dose Cytarabine Combined with Thalidomide Regimen.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
* Clearly diagnose and treat adult patients with multisystem or single-system multifocal LCH;
* Aged between 18 and 70 years;
* Multisystem involvement or single-system multifocal disease;
* No prior systemic treatment (patients who have only received local radiotherapy or surgery may be enrolled);
* ECOG performance status score ≤ 2;
* Judged by clinicians as suitable for treatment with this protocol;
* Patients or their families able to understand the study protocol and willing to participate in the study, providing written informed consent.
Exclusion Criteria:
* Patients with LCH involving the central nervous system;
* Single-system single-lesion LCH;
* Subjects who have undergone major surgery within 4 weeks prior to the first dose in the study;
* Subjects who have received radiotherapy within 4 weeks prior to the first dose in the study; subjects with a history of myocardial infarction within the past year;
* Patients with New York Heart Association (NYHA) class 3 or 4 congestive heart failure, or a history of NYHA class 3 or 4 congestive heart failure;
* Pregnant or lactating women;
* 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, bilirubin levels more than 10 times the upper limit of normal);
* Abnormal blood counts: absolute neutrophil count less than 1×10\^9/L, platelet count less than 50×10\^9/L;
* Patients or their families unable to understand the conditions and objectives of this study;
* Any other circumstances in which the investigator deems the patient unsuitable to participate in this trial.
Primary outcome measure(s)
Event-Free Survival (EFS) — From enrollment to the end of treatment until 3 years The primary endpoint was event-free survival (EFS), with events defined as poor response (stable disease or progressive disease) to cytarabine and thalidomide therapy, or death from any cause. EFS was measured from initiation of cytarabine and thalidomide therapy until the date of the first documented event, with censoring of patients without events at the 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
China
Recruiting
More Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials in China
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.
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