ACTRN12608000521325已完成1 期
Epstein-Barr Virus (EBV)-specific T cells as therapy for relapsed/refractory EBV-positive lymphomas
Queensland Institute of Medical Research (QIMR)0 个研究点目标入组 20 人开始时间: 2008年10月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 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
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1 Informed consent.
- •2 EBV-positive lymphoma as determined by in situ hybridization or equivalent (excluding Burkitts Lymphoma).
- •3 Age 18 years or older.
- •4 Eastern Cooperative Oncology Group (ECOG) performance status 1, 2 or 3
- •5 Life expectancy of at least 6 months.
- •6 Measurable disease: either relapsing, partially responsive, refractory or progressive disease, includes disease detected either by clinical examination, radiographic evaluation (including CT scans, and at physician’s discretion by functional imaging), or a persistently detectable plasma EBV viral load.
- •7 No chemotherapy / radiotherapy and/or antibody therapy for at least 2 weeks prior to anticipated date of first infusion.
排除标准
- •1 EBV negative tumour.
- •2 Presence of detectable malignant cells in the peripheral circulation by flow cytometry or morphology.
- •3 Serious infection within the past 28 days that has not adequately responded to therapy.
- •4 Pregnancy, or unwilling to use adequate contraception.
- •5 Serology (taken within 3 months of CTL release date) indicating active HBV or HCV infection, positive serology for HIV I&II, HTLV1 or syphilis.
- •6 Negative serology for EBV.
- •7 Psychiatric, addictive or any condition which may compromise the ability to participate in this trial
研究者
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