Efficacy and Safety of Interferon-Gamma Monoclonal Antibody Combined With Dexamethasone in the Treatment of Refractory Adult Secondary Hemophagocytic Lymphohistiocytosis
Key facts
- Who runs it
- Fudan University
- Where
- China1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 22 people enrolled
- Started
- 21 May 2024
- Ended
- 31 Aug 2025
- Type of study
- Observational
- Record updated
- 15 April 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- Concurrent use of other anti-neoplastic or investigational agents
- Active infection with mycobacteria, histoplasma, CMV, herpes zoster, or HIV
- Other uncontrolled infections judged by the investigator
- Psychiatric disorders or poor protocol compliance
- Left ventricular ejection fraction < 50%
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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:
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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.
The group in the trial
- Observation group
Participants receive IFN-γ monoclonal antibody by weight-based intravenous infusion. Dexamethasone is administered orally or intravenously. Prophylaxis for infections and standard supportive care are provided as clinically needed. Treatment continues for up to 8 weeks, with regular safety and efficacy assessments.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 15 April 2026