This study is trying to evaluate the efficacy and safety of dose-modified Emapalumab and Ruxolitinib (E-Ru) regimens for the treatment of active hemophagocytic lymphohistiocytosis.
Fulfillment of at least five of the eight HLH-2004 criteria for HLH;
Age 1-70 years old;
No prior chemotherapy for HLH;
Confirmed not pregnant and willing to use effective contraceptive measures during the study period, with the last dose of medication administered at least 12 months prior;
According to the New York Heart Association (NYHA) score, patients with heart disease of grade II or above (including grade II);
HIV-infected patients;
Patients with severe renal dysfunction (glomerular filtration rate <15 mL/min);
Patients with severe liver cirrhosis (MELD score>20);
Single group
dose-modified E-Ru
DrugEmapalumab (1-2 mg/kg intravenously once weekly for 8 weeks) + Ruxolitinib (15-30 mg orally twice daily for 8 weeks)
Salvage treatment and follow-up
Other intervention1\) for patients who did not respond to the E-Ru regimen after 7 days or who relapsed at any point during treatment, a rescue regimen such as HLH-94 or doxorubicin-etoposide-methylprednisolone (DEP) was administered; 2) for patients diagnosed with lymphoma after enrollment, chemotherapy was initiated; 3) for patients who completed 8 weeks of treatment without recurrence and had no detected HLH-related gene mutations, follow-up was initiated; and 4) for patients who met the criteria for allo-HSCT, allo-HSCT was performed.
60-days OS
overall survival (OS) rate at 60 days (2-month OS)
Response rate
The ORR was defined as the percentage of patients with a complete response (CR), a partial response (PR), or an improvement in the measures of HLH.
Security
Adverse events (AEs) were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE 5.0).
EFS
event-free survival, defined as the time from the first administration of E-Ru until no response on day 7, disease progression or death from any cause
Overall survival
OS (defined as the time from the first administration of E-Ru until death from any cause)
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
