ISRCTN89158144进行中（未招募）2 期
A phase II trial to assess the activity of Gemtuzumab Ozogamicin Therapy in Haemophagocytic lymphohistiocytosis (HLH) or Macrophage activation syndrome (MAS) or relapsed/refractory solid tumours (GOTHAM)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged >1 year old at the time of trial entry
- •2. Diagnosis of primary or secondary HLH or MAS disease that is relapsing/refractory to treatment at time of enrolment (Group 1)
- •3. Histologically confirmed diagnosis of solid cancer with radiological or clinical evidence of disease progression (during or after completion of at least one previous treatment) or any subsequent recurrence (biopsy at relapse is not mandated) (Group 2)
- •Note: patients who meet the inclusion criteria for both groups 1 and 2 should be entered into group 1
- •3.1.Group 2 only – must have adequate liver function:
- •3.1.1. Total bilirubin =x2 upper limit of normal (ULN)
- •3.1.2. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =2.5 x ULN
- •4. Documented negative pregnancy test for female patients of childbearing potential within 7 days prior to trial entry
- •5. Sexually active patients must agree to use 2 methods of adequate and appropriate contraception while on trial drug and for 4 months (male) and 7 months (female) following treatment discontinuation
- •6. Written informed consent given by patient and/or parents/legal guardian
排除标准
- •1. Evidence of sinusoidal obstruction syndrome (SOS)/veno-occlusive disease (VOD)
- •2. Previous treatment with another CD33 targeting antibody or immunotoxin
- •3. Hypersensitivity to gemtuzumab ozogamicin or to any of the excipients
- •4. Pregnant or lactating female
研究者
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