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

NCT06951971 · tracked via the Priya Life Science China tracker

Sponsor

The First Affiliated Hospital of Soochow University

Phase

Phase 2/3

Started

2025-06-01

Last updated

2025-04-30

Condition(s) studied

Hemophagocytic Lymphohistiocytosis (HLH)

Investigational drug(s) / intervention(s)

dose-modified E-RuSalvage treatment and follow-up

dose-modified E-Ru: Emapalumab (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: 1\) 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.

Study 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.

Eligibility

Sex

ALL

Min age

1 Year

Max age

70 Years

Healthy volunteers

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.

Primary outcome measure(s)

60-days OS — 60 days
overall survival (OS) rate at 60 days (2-month OS)

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06951971 on ClinicalTrials.gov ↗ ← All trials in China