critical hemophagocytic syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age 16-70 years old, gender not limited, meets the HLH-2004 diagnostic criteria; 2.HLH patients with SOFA Score 2 or more of at least one organ system excluding coagulation/hematologic system,and/or any need for organ replacement therapy due to organ failure, including positive-pressure ventilation, renal replacement therapy, vasopressors, and extracorporeal life support; 3.Expected survival period exceeds one month; 4.No history of drug allergies within the protocol; 5.Participants with pregnancy plans must agree to use contraception before enrollment in the study and after the study lasts for six months; If the subject is pregnant or suspected of being pregnant, the researcher should be notified immediately; 6.The subjects understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Uncontrolled active infections (including bacterial, fungal, or viral infections), unless the researchers consider the infection to be related to HLH; 2.Participate in other clinical studies, or plan to start treatment in this study less than 4 weeks after the end of the previous clinical study treatment; 3.Have a history of allergies to the drugs within the protocol; 4.Female subjects are in pregnancy and lactation period; 5.Human immunodeficiency virus (HIV) infection or syphilis infection; 6.Active hepatitis that has not been controlled after active antiviral treatment; 7.Other situations that researchers consider unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;duration of response?Progression-freesurvival?Overall survival; | — |
Countries
China
Contacts
The First Affiliated Hospital of Soochow University