NCT06038422尚未招募3 期
Clinical Study on Efficacy and Safety of GTP Regimen in the Treatment of Refractory/Recurrent Hemophagocytic Lymphohistiocytosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 15
- 主要终点
- ORR
研究概览
简要总结
The goal of this clinical trial is to learn about efficacy and safety of GTP regimen in refractory/recurrent hemophagocytic lymphohistiocytosis. The main questions it aims to answer are:
- Overall remission rate of GTP regimen in R/R HLH
- Adverse effect of GTP regimen Participants will be treated with GTP regimen
详细描述
Refractory/recurrent hemophagocytic lymphohistiocytosis will be treated with emapalumab combined with teniposide and methylprednisolone. Observed the overall response rate and side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients ≥1 month of age with HLH
- •Definitive diagnosis of HLH: meets the molecular diagnosis of pHLH or has a family history of HLH, or meets at least 5 of the 8 diagnostic criteria of HLH-
- •The investigators assessed the presence of refractory/recurrent HLH disease. Patients must meet one of the following criteria assessed by the investigator:
- •Previous conventional HLH treatment did not respond.
- •The patients were not satisfied with the efficacy of conventional HLH treatment or their condition worsened.
- •HLH reactivation occurs. Reactivation is defined as: worsening of two or more HLH clinical and laboratory criteria (after initial remission).
- •According to the researchers, the expected survival was more than 2 weeks.
- •The informed consent is signed by the patient or his legal guardian (patients under 18 years), or by the patient's legally authorized representative.
- •Women who are fertile are willing to use a highly effective contraceptive method from the start of the study until 6 months after the end of the last course of treatment.
排除标准
- •There is active mycobacterium, histoplasma capsulatus, Salmonella, or leishmania infection.
- •There is uncontrolled active gastrointestinal bleeding.
- •The investigator believes that there are any serious comorbidities or any other conditions that make the patient unsuitable for treatment.
- •A history of hypersensitivity or hypersensitivity to any component of the drug in the study protocol, such as polysorbate.
- •Had received the BCG vaccine within 12 weeks prior to screening.
- •Have received live or attenuated vaccine (except BCG) within 4 weeks prior to screening.
- •Pregnancy patients.
- •Within 4 weeks prior to enrollment in this study, another concurrent clinical intervention study was enrolled.
- •There is any condition or circumstance that the investigator believes may cause the patient to be unable to complete the study or to comply with study procedures or requirements.
研究组 & 干预措施
GTP regimen treated patients
Experimental
R/R HLH patients treated with GTP regimen
干预措施: GTP regimen (Drug)
结局指标
主要结局
ORR
时间窗: 1 year
Overall remission rate
次要结局
未报告次要终点
研究者
Zhao Wang
director of department
Beijing Friendship Hospital
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