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 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT05546060
Eligibility Criteria:
Inclusion Criteria:
* age ≥18 years old, expected survival time more than 3 months;
* met HLH-2004 diagnostic criteria；
* ECOG score 0-2；
* ECG QTcF interval: male ≤450ms, female ≤470ms;
* AST and ALT ≤3.0 ULN, TB ≤1.5×ULN；serum creatinine≤1.5×ULN，or CrCL ≥ 50mL/min；INR、APTT、PT ≤1.5×ULN；
* without pregnancy or lactation, and agree to contraception during and for at least 6 months after the study；
* signed informed consent.
Exclusion Criteria:
* patients with malignancies unrelated to HLH, except for fully recovered non-melanoma skin cancer and carcinoma in situ;
* patients participated in other clinical trials within 4 weeks；
* previously treated with Bcl-2 inhibitors；
* unable to take oral medication；
* history of substance abuse or patients with mental illness；
* severe infection；
* cardiovascular disease，NYHA II-IV；
* allergic to venetoclax or etoposide.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05546060
Study Brief:
Protocol Section:
NCT05546060