Dose-modified Emapalumab and Ruxolitinib (E-Ru) Regimens for Hemophagocytic Lymphohistiocytosis

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Apr 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two medications, Emapalumab and Ruxolitinib, to see how well they work and how safe they are for treating a serious condition called hemophagocytic lymphohistiocytosis (HLH). HLH is a condition where the immune system goes into overdrive and starts attacking the body's own cells. The trial is looking for participants aged 1 to 70 years who meet specific criteria, such as having certain symptoms of HLH, and who have not received chemotherapy for this condition before.

If you or someone you know is interested in participating, it’s important to know that participants will be carefully monitored throughout the study. However, there are some individuals who cannot join, such as those with certain heart conditions, severe infections, or active tumors. Before joining, participants will need to provide informed consent, meaning they agree to the study and understand what it involves. Since the study is not yet recruiting, more details will be available once it starts.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Fulfillment of at least five of the eight HLH-2004 criteria for HLH;
• • 2. Age 1-70 years old;
• • 3. No prior chemotherapy for HLH;
• • 4. 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;
• • 5. Signed informed consent prior to study participation.
• Exclusion Criteria:
• • 1. According to the New York Heart Association (NYHA) score, patients with heart disease of grade II or above (including grade II);
• • 2. HIV-infected patients;
• • 3. Patients with severe renal dysfunction (glomerular filtration rate \<15 mL/min);
• • 4. Patients with severe liver cirrhosis (MELD score\>20);
• • 5. Uncontrollable infections (including lung infections, intestinal infections, etc.);
• • 6. Have serious mental illness;
• • 7. Have a history of active tumor;
• • 8. Participate in other clinical investigators at the same time;
• • 9. People with central nervous system involvement;
• • 10. Exclusion criteria related to concomitant medication.