Status:
NOT_YET_RECRUITING
Dose-modified Emapalumab and Ruxolitinib (E-Ru) Regimens for Hemophagocytic Lymphohistiocytosis
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
Hemophagocytic Lymphohistiocytosis (HLH)
Eligibility:
All Genders
1-70 years
Phase:
PHASE2
PHASE3
Brief Summary
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.
Detailed Description
This clinical trial is designed to evaluate a new treatment strategy for patients with active Hemophagocytic Lymphohistiocytosis (HLH)-a rare but severe immune disorder characterized by excessive infl...
Eligibility Criteria
Inclusion
- 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;
- Signed informed consent prior to study participation.
Exclusion
- 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);
- Uncontrollable infections (including lung infections, intestinal infections, etc.);
- Have serious mental illness;
- Have a history of active tumor;
- Participate in other clinical investigators at the same time;
- People with central nervous system involvement;
- Exclusion criteria related to concomitant medication.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06951971
Start Date
June 1 2025
End Date
June 1 2028
Last Update
April 30 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006