hemophagocytic lymphohistiocytosis
Conditions
Interventions
Ruxolitinib:5 mg or 10 mg twice daily depending on the body weight (20kg, respectively) by oral for 28 days
Sponsors
Beijing Children's Hospital, Capital Medical University, National Center for Children's Health
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: (1) met HLH-2004 diagnostic criteria; (2) newly diagnosed HLH patients; (3) no prior chemotherapy treatment for HLH before screening; (4) male or female, less than 18 years of age; (5) signed informed consent form before participating in the study.
Exclusion criteria
Exclusion criteria: patients with serious renal failure, hepatic failure, parasitic infection, history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric were ineligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the overall response (OR) rate at day 28 of the last dose, including proportion of patients achieving a complete response (CR) and proportion of a partial response (PR); | — |
Secondary
| Measure | Time frame |
|---|---|
| event-free survival time (EFS, defined as the time from initial ruxolitinib treatment to the first occurrence of disease progression, relapse or death; for non-responders, EFS is defined as date of enrollment plus 1 day);the duration of response;dynamic changes of key biomarkers during treatment;the association between treatment response and risk stratification;safety; | — |
Countries
China
Contacts
Public ContactZhang Rui
Beijing Children's Hospital, Capital Medical University, National Center for Children's Health
Outcome results
None listed