ACTRN12618000343202已完成1 期
Therapeutic infusion of most closely HLA-matched third party donor-derived virus-specific cytotoxic T-lymphocytes in patients with previously untreated viral infection post-allogeneic stem cell transplantation
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
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 stem cell transplantation for any indication.
- •2) Reactivation or infection with cytomegalovirus (CMV), Adenovirus (Adv) or Epstein-Barr virus (EBV) or EBV associated post-transplant lymphoproliferative disease (PTLD) must be present at the time of infusion as determined by:
- •- CMV detectable by antigen detection, Polymerase chain reaction (PCR) or culture in peripheral blood or tissue biopsy or by immunohistochemical staining on tissue biopsy specimen within 7 days of trial inclusion
- •- AdV detectable by antigen detection, PCR or culture in body fluids including blood, stool, urine or nasopharyngeal secretions or by immunohistochemical staining on tissue biopsy specimen within 7 days of trial inclusion
- •o For EBV, any of the following within 7 days of trial inclusion
- •- 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) Patients must satisfy criteria for initiation of treatment
- •- Most recent PCR in peripheral blood greater than or equal to 1,000 viral genome copies/ml OR positive antigen detection, PCR or culture in tissue in association with clinical symptoms and/or signs consistent with CMV tissue infection
- •- For asymptomatic patients (ie no fever, diarrhoea, respiratory symptoms etc):
- •Most recent PCR in peripheral blood greater than or equal to 1000 viral genome copies/ml in blood OR 2 positive PCR tests in any organ system that was negative prior to transplant
- •- For symptomatic patients:
- •1 positive PCR test from a symptomatic organ or in blood OR 2 positive PCR tests in any organ system that was negative prior to transplant
- •- Most recent PCR in peripheral blood greater than or equal to 10,000 viral genome copies/ml OR positive antigen detection, PCR or culture in tissue in association with clinical symptoms and/or signs consistent with EBV tissue infection or EBV associated post-transplant lymphoproliferative disease
- •4) Patients must not have received more than 7 days of prior treatment dose pharmacological anti-viral therapy at the time of T cell infusion. Treatment dose pharmacological therapy is defined as:
- •- IV ganciclovir or foscarnet at full dose or high dose acyclovir or one of its derivatives or brincidofovir (doses of aciclovir of 800 mg bd or valaciclovir 1 g/day or below will not be considered treatment dose).
- •- cidofovir or brincidofovir
- •- rituximab
- •- cytotoxic chemotherapy
- •5) 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)
- •6) ECOG status 0 to 3 or Lansky score 30-100
- •7) 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 unless anti-lymphocyte globulin levels in blood shown to be below the lympholytic threshold prior to infusion.
- •2) Active grade II or greater graft versus host disease within 1 week prior to infusion.
- •3) Prednisone or methylprednisolone at a dose of > 1 mg/kg (or equivalent in other steroid preparations) administered within 72 hours prior to cell infusion.
- •4) Dose of prednisone or methylprednisolone (if administered) not maintained at a stable level for 72 hours prior to T cell infusion
- •5) ECOG status 4 or Lansky score <30
研究者
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