ACTRN12609000531213已完成1 期
Adoptive immunotherapy for the treatment of cytomegalovirus (CMV) reactivation and disease after transplantation.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
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 75 Years（—）
- 性别
- All
入选标准
- •1) HSCT/SOT recipients who were transplanted by, and/or are currently under the care of, a haematologist or physician at the appropriate clinical facility.
- •2). CMV infection that falls into one of the following categories:
- •(a) Recurrent CMV reactivation (as defined by PCR) or disease (as defined by histology) following successful initial therapy, or
- •(b) Persistent CMV disease (no response to 2 weeks of salvage foscarnet or other second line antiviral agent), or
- •(c) Persistent CMV replication (more than 6 weeks by PCR) despite appropriate antiviral therapy, or
- •(d) Any CMV reactivation or disease where anti-viral therapy is contraindicated on the basis of intolerance or end organ limitation (e.g. renal impairment, marrow dysfunction).
- •3) Absence of uncontrolled intercurrent infection
- •4) Patient able to provide informed consent
- •5) Age 18 to 75
排除标准
- •1 Uncontrolled intercurrent infection
- •2 Eastern Cooperative Oncology Group (ECOG)status > 3 (Karnofsky performance score < 30: disabled, no self-care. Totally bedridden, or confined to chair)
- •3 Markers of active Hepatitis B virus (HBV), Hepatitis C virus (HCV) or Human immunodeficiency virus (HIV) infection (presence of Hepatitis B surface Antigen (HBsAg), Hepatitis C (HepC) antibody, or HIV antibodies)
- •4 Uncontrolled Graft versus Host disease (GVHD)
- •5 Steroid doses > 1mg/kg of prednisone, or equivalent
研究者
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