HLH-2004 Treatment Protocol
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 368
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
Without therapy HLH is often fatal, and often rapidly fatal. The treatment protocol HLH-94 has improved survival markedly as compared to the survival earlier. We now aim to improve survival further.
详细描述
The most dangerous period after HLH diagnosis is the first 2 months. In HLH-2004 we provide additional therapy during this period as compared to in HLH-94.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who fulfil the diagnostic criteria of HLH.
排除标准
- •Prior cytotoxic or cyclosporin treatment for HLH.
研究组 & 干预措施
Etoposide, Dexamethasone, Cyclosporin A plus IT MTX & Steroids
As compared to the HLH-94 treatment, the main changes are that
- Cyclosporin A is administered from day 1 and
- Intrathecal steroids are added to the intrathecal methotrexate.
Drugs, dosage, frequency and duration are described in the paragraph "Interventions" below.
干预措施: Dexamethasone (Drug)
Etoposide, Dexamethasone, Cyclosporin A plus IT MTX & Steroids
As compared to the HLH-94 treatment, the main changes are that
- Cyclosporin A is administered from day 1 and
- Intrathecal steroids are added to the intrathecal methotrexate.
Drugs, dosage, frequency and duration are described in the paragraph "Interventions" below.
干预措施: Etoposide (Drug)
Etoposide, Dexamethasone, Cyclosporin A plus IT MTX & Steroids
As compared to the HLH-94 treatment, the main changes are that
- Cyclosporin A is administered from day 1 and
- Intrathecal steroids are added to the intrathecal methotrexate.
Drugs, dosage, frequency and duration are described in the paragraph "Interventions" below.
干预措施: Cyclosporin (Drug)
Etoposide, Dexamethasone, Cyclosporin A plus IT MTX & Steroids
As compared to the HLH-94 treatment, the main changes are that
- Cyclosporin A is administered from day 1 and
- Intrathecal steroids are added to the intrathecal methotrexate.
Drugs, dosage, frequency and duration are described in the paragraph "Interventions" below.
干预措施: Intrathecal therapy (Procedure)
Etoposide, Dexamethasone, Cyclosporin A plus IT MTX & Steroids
As compared to the HLH-94 treatment, the main changes are that
- Cyclosporin A is administered from day 1 and
- Intrathecal steroids are added to the intrathecal methotrexate.
Drugs, dosage, frequency and duration are described in the paragraph "Interventions" below.
干预措施: Stem cell transplant (Procedure)
结局指标
主要结局
Survival
时间窗: 1-year after diagnosis
次要结局
- Late effects(5-years after diagnosis)
研究者
Jan-Inge Henter
Professor
Karolinska University Hospital