Efficacy and Safety of Interferon-Gamma Monoclonal Antibody Combined With Dexamethasone in the Treatment of Refractory Adult Secondary Hemophagocytic Lymphohistiocytosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 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.
次要结局
- Progression-Free Survival (PFS)(Up to 12 months after treatment initiation)
- Overall Survival (OS)(Up to 12 months after treatment initiation)
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to 28 days after the last dose of study treatment)