Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT07187193
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07187193
Study Brief:
Protocol Section:
NCT07187193