ACTRN12613000603718招募中1 期
In allogeneic stem cell transplant patients, with viral reactivation unresponsive to standard antiviral therapy, is therapeutic infusion of most closely HLA-matched, third party, donor-derived, virus-specific cytotoxic T-lymphocytes, safe and efficacious?
Western Sydney Local Health Districit0 个研究点目标入组 30 人开始时间: 2013年5月28日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 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
- o limit 至 o limit（—）
- 性别
- All
入选标准
- •1. Recipients of myeloablative or non-myeloablative allogeneic transplantation for any indication.
- •2. Viral reactivation or infection with CMV, Adv or EBV as determined by:
- •- CMV detectable by antigen detection, PCR or culture in peripheral blood or tissue biopsy or by immunohistochemical staining on tissue biopsy specimen
- •- Presence of Adv as detected by PCR, antigen detection or culture in body fluids including blood, stool, urine or nasopharyngeal secretions
- •- Elevated EB virus detectable in peripheral blood by PCR or
- •- Presence of documented EBV related PTLD diagnosed by tissue biopsy or
- •- Elevated EB virus detectable in the blood by PCR and clinical or imaging findings consistent with EBV lymphoma
- •3. Failure of standard therapy as defined by:
- •- The continued presence of detectable CMV virus or antigen after at least 14 days of antiviral therapy with IV ganciclovir or foscarnet
- •- Recurrence of detectable CMV virus or antigen after at least 2 weeks of prior antiviral therapy
- •- A rise or less than 50% reduction in viral load in blood or any site of disease as measured by PCR or any quantitative assay despite use of therapy as determined by the treating physician (standard therapy may include intravenous cidofovir within the limits of renal function)
- •- Increase or less than 50% decrease in the size of EBV lymphoma or
- •- Increase or less than 50% decrease in the EBV viral load in peripheral blood despite use of appropriate therapy as determined by the treating physician which may include:
- •- Reduction in immunosuppression
- •- Rituximab 375mg/m2 up to 4 infusions
- •- Cytotoxic chemotherapy
- •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. ECOG status 0 to 3
- •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. ECOG status 4
- •5. Privately insured patients (dependent on site)
研究者
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