Efficacy and Safety of Low-Dose Cytarabine Combined With Thalidomide in Adult Patients With Untre… (NCT07187193) | Clinical Trial Compass
RecruitingPhase 2
Efficacy and Safety of Low-Dose Cytarabine Combined With Thalidomide in Adult Patients With Untreated LCH
China50 participantsStarted 2025-04-12
Plain-language summary
Treatment of Adult Patients with Newly Diagnosed Langerhans Cell Histiocytosis (LCH) Using a Low-Dose Cytarabine Combined with Thalidomide Regimen.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
…
What they're measuring
1
Event-Free Survival (EFS)
Timeframe: From enrollment to the end of treatment until 3 years
Trial details
NCT IDNCT07187193
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences