NCT00509691已完成1 期
A Phase I Trial to Examine the Safety, Clinical, Immunologic and Virologic Effects of CMV pp65 Specific Cytotoxic T Lymphocytes for Recipients of Allogeneic Stem Cell Transplants With Persistent or Therapy Refractory Infections
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Toxicity
研究概览
简要总结
RATIONALE: Vaccines may help the body build an effective immune response to kill cytomegalovirus infections.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients who have undergone a donor stem cell transplant and have cytomegalovirus infection that has not responded to therapy.
详细描述
OBJECTIVES:
Primary
- To determine the safety of infusing cytomegalovirus (CMV) pp65-specific cytotoxic T-lymphocytes (CTL) generated using pp65 peptides in patients who have undergone allogeneic stem cell transplantation and have persistent CMV infections.
Secondary
- Characterize CMV pp65-specific immune responses in terms of cytotoxicity and cytokine production pre-infusion and then periodically thereafter.
- Characterize the levels of CMV DNA in recipients of CMV pp65 CTL and observe whether the CTL infusion has any impact on the level of virus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Cytomegalovirus (CMV) seropositive
- •Patient has had CMV antigenemia for ≥ 2 weeks OR CMV DNA levels ≥ 600 copies/μg of DNA despite antiviral therapy targeting CMV (ganciclovir or foscarnet)
- •No prior allogeneic stem cell transplantation before the most recent transplantation
- •CMV seropositive donor negative for HIV-1, HIV-2, HTLV-1/2 available
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2 (for patients ≤ 16 years of age) OR Lansky performance status 70-100%
- •Bilirubin < 2.0 mg/dL
- •AST and ALT < 2.5 times upper limit of normal
- •Creatinine clearance > 50 mL/min
- •Pulse oximetry > 95% without supplemental oxygen
- •No history of graft-vs-host disease (GVHD) ≥ grade 2
- •Not moribund
- •No patients not expected to survive 1 month after T cell infusion due to cardiac, pulmonary, renal, hepatic, or neurologic dysfunction
- •PRIOR CONCURRENT THERAPY:
- •No concurrent systemic immunosuppressive agents for the treatment of GVHD
排除标准
- 未提供
研究组 & 干预措施
Single arm study
Experimental
干预措施: diagnostic laboratory biomarker analysis (Other)
Single arm study
Experimental
干预措施: flow cytometry (Other)
Single arm study
Experimental
干预措施: immunologic technique (Other)
Single arm study
Experimental
干预措施: cytomegalovirus pp65-specific cytotoxic T lymphocytes (Biological)
Single arm study
Experimental
干预措施: polymerase chain reaction (Genetic)
结局指标
主要结局
Toxicity
时间窗: 1 year
Safety
时间窗: 1 year
Treatment failure
时间窗: 1 year
次要结局
- CMV DNA levels(1 year)
- Time during post-infusion follow up at which the dominant CMV pp65 epitope for the donor is recognized by the cytotoxic t-cell lymphocyte recipient(1 year)
- Time to development of cytomegalovirus (CMV) specific immune reconstitution(1 year)
研究者
研究点 (1)
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