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Dose-modified Emapalumab and Ruxolitinib for Hemophagocytic Lymphohistiocytosis

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What is being tested

dose-modified E-Ru

+ Salvage treatment and follow-up

DrugOther
Who is being recruted

Hemic and Lymphatic Diseases+2

+ Lymphatic Diseases

+ Histiocytosis

From 1 to 70 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2 & 3
Interventional
Study Start: June 2025
See protocol details

Summary

Principal SponsorThe First Affiliated Hospital of Soochow University
Study ContactYue Song, Dr
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2025

Actual date on which the first participant was enrolled.

This clinical trial investigates a new treatment method for individuals with active Hemophagocytic Lymphohistiocytosis (HLH), a serious disorder where the immune system becomes overly active and causes harmful inflammation. HLH is rare but can be fatal if not managed correctly. The study focuses on patients experiencing this condition and aims to provide insights into more effective treatment options. By exploring this new treatment approach, the study hopes to enhance patient outcomes and offer better management strategies for HLH. Participants in this trial will receive a combination of two medications designed to address the excessive immune activity in HLH. Emapalumab, a monoclonal antibody, will be given at a reduced dose to minimize side effects, and it works by blocking a protein that drives the immune overreaction. Ruxolitinib, another medication involved, will be administered at a higher dose to boost its effectiveness in reducing inflammation by targeting specific pathways in the immune system. The study is conducted across multiple healthcare centers, where patients will be monitored over time to evaluate the safety and effectiveness of this treatment combination.

Official TitleA 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
Principal SponsorThe First Affiliated Hospital of Soochow University
Study ContactYue Song, Dr
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 1 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesLymphatic DiseasesHistiocytosisHistiocytosis, Non-Langerhans-CellLymphohistiocytosis, Hemophagocytic

Criteria

5 inclusion criteria required to participate
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;

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10 exclusion criteria prevent from participating
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);

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
dose-modified Emapalumab+Ruxolitinib for the treatment of HLH patients.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

The First Affiliated Hospital of Soochow University

Suzhou, ChinaOpen The First Affiliated Hospital of Soochow University in Google Maps
Recruiting soonOne Study Center