Prevention and Treatment of CMV Disease by Adoptive Immunotherapy With Immune Donor Lymphocytes in Conjunction With Non-myeloablative Stem Cell Transplantation (NST)
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Induce and amplify T cell-mediated immunotherapy against cytomegalovirus (CMV) infection in stem cell allograft recipients.
研究概览
简要总结
Treatment strategy of patients:
Stem cell engraftment (myeloablative or NST) for induction of host vs graft myeloablative transplantation tolerance.
Whenever indicated, additional post NST DLI given in graded increment, to optimize control of GVHD.
Preparation of immune donor lymphocytes, either by donor immunization in-vitro with a CMV-specific peptide followed by administration of immunized donor lymphocytes, or by injection of donor lymphocytes and in-vivo sensitization of donor lymphocytes in the patient following DLI.
Pre-emptive treatment of seronegative patients at risk or patients with documented viremia or CMV disease with CMV-specific donor lymphocytes generated in-vivo in the donor or in the host by peptide immunization.
Consenting donors will be immunized with CMV-specific peptides, for induction of CTLs in-vivo following subcutaneous inoculation of peptides with adjuvant or donor APC pulsed with relevant peptides.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For Patient:
- •Consenting patients with indication for myeloablative BMT or NST with an HLA matching sibling available, for transplant.
- •Patients at risk of CMV disease including seronegative patients; patients with seronegative donors, and seronegative donor for sero positive patients.
- •Patients with resistant CMV viremia or CMV disease not responding to conventional treatment with ganciclovir, or Foscarnet.
- •Patients with HLA phenotype for which a relevant peptide for CMV exists.
- •For Donor:
- •Consenting sibling >18 years old.
- •HLA phenotype for which a relevant peptide for CMV exists.
排除标准
- •For Patient:
- •Patients with severe resistant GVHD where there may be a risk to administer DLI or immunized donor lymphocytes.
- •For Donor:
- •Consenting sibling >18 years old.
- •HLA phenotype for which a relevant peptide for CMV exists.
- •Donor with an infectious disease (e.g. HIV-1; HBV, etc.)
结局指标
主要结局
Induce and amplify T cell-mediated immunotherapy against cytomegalovirus (CMV) infection in stem cell allograft recipients.
次要结局
- Evaluate toxicity of the procedure.