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 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT05775705
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed as lymphoma-Hemophagocytic Lymphohistiocytosis.
* EBV-DNA in peripheral blood \> 1000 copies/ml or EBER detected in tissue specimens.
* Age 18\~65，gender is not limited.
* Estimated survival time ≥ 1 month.
* Cardiac ultrasound LVEF≥50%; No Active bleeding of the internal organs(digestive tract, lung, brain, etc.); If the patient has dyspnea, oxygenation index \>250.
* Signed informed consent.
Exclusion Criteria:
* Heart function above grade II (NYHA).
* Severe myocardial injury：TNT、TNI、CK-MB \> 3 ULN.
* Accumulated dose of doxorubicin above 400mg/m2 、epirubicin above 750mg/m2、pirarubicin above 800mg/m2 or the patients treated with anthracycline induced cardiovascular disease.
* Pregnancy or lactating Women.
* Allergic to pegylated liposomal doxorubicin，etoposide，or PD-1 antibody.
* Thyroid dysfunction.
* HIV antibody positivity.
* Acute or chronic active hepatitis B (HBsAg positivity, HBV DNA negative acceptable), acute or chronic active hepatitis C (HCV antibody negatively acceptable; HCV antibody positivity, HCV RNA negative acceptable).
* Participate in other clinical research at the same time.
* The researchers considered that patients are not suitable for the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05775705
Study Brief:
Protocol Section:
NCT05775705