Efficacy and Safety of Low-Dose Cytarabine Combined With Thalidomide in the Treatment of Adult Patients With Untreated Langerhans Cell Histiocytosis: A Prospective, Multicenter, Single-Arm Study.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
Treatment of Adult Patients with Newly Diagnosed Langerhans Cell Histiocytosis (LCH) Using a Low-Dose Cytarabine Combined with Thalidomide Regimen.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
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
RECRUITING
Beijing
Contact Information
Primary
Xinxin XX Cao, doctor
caoxinxin@126.com
+86-18618315968
Backup
Huilei HL Miao, doctor
miaohl13@163.com
+86-18801317695
Time Frame
Start Date: 2025-04-12
Estimated Completion Date: 2027-04-13
Participants
Target number of participants: 50
Treatments
Experimental: Newly diagnosed LCH patients
(1) The histopathological diagnosis of LCH is confirmed; (2) Multi-system involvement or single-system with multiple lesions; (3) No prior systemic treatment (patients who have only received local radiotherapy or surgery are eligible);
Related Therapeutic Areas
Sponsors
Leads: Cancer Institute and Hospital, Chinese Academy of Medical Sciences