Status:
RECRUITING
Efficacy and Safety of Low-Dose Cytarabine Combined With Thalidomide in Adult Patients With Untreated LCH
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Langerhans Cell Histiocytosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Treatment of Adult Patients with Newly Diagnosed Langerhans Cell Histiocytosis (LCH) Using a Low-Dose Cytarabine Combined with Thalidomide Regimen.
Detailed Description
AraC 100 mg/m² d1-5+ thalidomide 100mg d1-35, q35 days ,for a total of 12 cycles;followed by thalidomide 100mg, qd1-28 q28d,for a total of 12 cycles of monotherapy maintenance reatment;
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 13 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07187193
Start Date
April 12 2025
End Date
April 13 2027
Last Update
September 22 2025
Active Locations (1)
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1
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