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NOT YET RECRUITING
NCT06951971
PHASE2/PHASE3

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

Sponsor: The First Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

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.

Official title: A Multiple Center, Prospective, Single Arm, Phase III Clinical Study to Evaluate the Efficacy and Safety of Dose-modified Emapalumab and Ruxolitinib in the Treatment of Hemophagocytic Lymphohistiocytosis

Key Details

Gender

All

Age Range

1 Year - 70 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-06-01

Completion Date

2028-06-01

Last Updated

2025-04-30

Healthy Volunteers

No

Interventions

DRUG

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)

OTHER

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.

Locations (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China