Efficacy and Safety of Interferon-Gamma Monoclonal Antibody Combined With Dexamethasone in the Treatment of Refractory Adult Secondary Hemophagocytic Lymphohistiocytosis

The goal of this observational study is to learn if interferon-gamma monoclonal antibody combined with dexamethasone works to treat adults with refractory secondary hemophagocytic lymphohistiocytosis (HLH). The main questions it aims to answer are:

How well does this treatment help patients recover from refractory secondary HLH? How safe is this treatment for these patients? Participants will receive interferon-gamma monoclonal antibody and dexamethasone as part of their clinical care. Researchers will monitor participants with regular blood tests, physical exams, and safety checks for up to 8 weeks of treatment. They will collect information about how participants respond to treatment and any side effects that occur.

This study will include about 22 adult participants at Huadong Hospital Affiliated to Fudan University.

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Key information

Conditions

Adult Refractory Secondary Hemophagocytic Lymphohistiocytosis HLH Secondary Hemophagocytic Lymphohistiocytosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Huadong Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥ 18 years
Confirmed diagnosis of secondary hemophagocytic lymphohistiocytosis (HLH) according to HLH-2004 criteria
Refractory HLH defined as inadequate response or progression after at least 2 weeks of standard first-line or second-line therapy
Able to provide written informed consent

Exclusion criteria

Active infection with mycobacteria, histoplasma, CMV, herpes zoster, or HIV
Left ventricular ejection fraction < 50%
Concurrent use of other anti-neoplastic or investigational agents
Other uncontrolled infections judged by the investigator
Psychiatric disorders or poor protocol compliance

Treatment and study plan

Primary outcomes

Overall Response Rate (ORR)

Time frame: Up to 8 weeks after initiation of treatment

The proportion of participants who achieve complete response (CR) or partial response (PR) at the end of 8-week treatment, defined by normalized or improved clinical and laboratory parameters including ferritin, triglycerides, sCD25, blood cell counts, and hemophagocytosis.

Secondary outcomes

Progression-Free Survival (PFS)

Time frame: Up to 12 months after treatment initiation

Time from treatment start to disease progression or death from any cause, whichever occurs first.
Overall Survival (OS)

Time frame: Up to 12 months after treatment initiation

Time from treatment start to death from any cause.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: Up to 28 days after the last dose of study treatment

Number and severity of treatment-emergent adverse events and serious adverse events, graded according to NCI-CTCAE v5.0.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Apr 15, 2026
Registry last updated: Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed