ACTRN12612000800820尚未招募1 期
In haemopoietic stem cell transplant patients, does infusion of infection-specific T-cells combined with vaccination (compared to no vaccination) enhance immune reconstitution safely?
Professor DJ Gottlieb0 个研究点目标入组 18 人开始时间: 2012年7月31日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 18
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
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- o limit 至 o limit（—）
- 性别
- All
入选标准
- •1. Patients undergoing myeloablative or non-myeloablative allogeneic transplantation from an HLA (A, B and DR) identical or 1-3 antigen mismatched family or unrelated donor.
- •2. Transplant performed for any type of non-malignant condition or haematological malignancy including but not limited to acute and chronic leukaemia, myelodysplasia, non Hodkgins and Hodgkins lymphoma or myeloma.
- •3. Recipients of peripheral blood or bone marrow stem cells.
- •4. Adequate hepatic and renal function (< 3 x upper limit of normal for AST (SGOT), ALT (SGPT), < 2 x upper limit of normal for total bilirubin, serum creatinine).
- •5. Estimated life expectancy of at least 6 months.
- •6. Patient (or legal representative) has given informed consent.
排除标准
- •1. Use of anti-lymphocyte globulin (ALG, ATG, Campath or other broad spectrum lymphocyte antibody) given in the 4 weeks immediately prior to infusion or planned within 4 weeks after infusion.
- •2. Grade II or greater graft versus host disease within 1 week prior to infusion.
- •3. Prednisone or methylprednisone at a dose of > 1 mg/kg (or equivalent in other steroid preparations) administered within 72 hours prior to cell infusion.
- •4. Allergies to eggs or components of the Fluvax or Varivax vaccines.
研究者
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