NCT00769613Unknown1 期
Emergency Access to C.V. pp65 / IE-1 Specific Cytotoxic T Lymphocytes for Recipients of Allogeneic Stem Cell Transplants With Persistant or Therapy Refractory Infections
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
RATIONALE: White blood cells that have been treated in the laboratory may kill cells that are infected with cytomegalovirus.
PURPOSE: This phase I trial is studying how well cytotoxic T cells work in treating patients who have undergone donor stem cell transplant and have cytomegalovirus infections.
详细描述
OBJECTIVES:
Primary
- To provide access to cytomegalovirus (CMV) pp65- and IE-1-specific cytotoxic T lymphocytes (CTL) in patients with persistent CMV infections after allogeneic stem cell transplantation.
Secondary
- To characterize CMV pp65- and IE-1-specific immune responses in terms of cytotoxicity and cytokine production pre-infusion and then periodically thereafter.
- To characterize the levels of CMV DNA in recipients of CMV pp65- and IE-1-specific CTL and observe whether the CTL infusion has any impact on level of virus.
- To determine the feasibility of CMV CTL culture from CMV-seronegative donors who have received a CMV vaccine.
研究设计
- 研究类型
- Interventional
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Recipient of an allogeneic stem cell transplantation
- •Cytomegalovirus (CMV)-seropositive and meeting 1 of the following criteria:
- •Patient has a history of CMV antigenemia for ≥ 2 weeks
- •CMV DNA levels ≥ 600 copies/mcg of DNA despite antiviral therapy targeting CMV (e.g., ganciclovir or foscarnet)
- •No ongoing graft-vs-host disease
- •Has donor available for peripheral blood mononuclear cell collection (for cytotoxic T lymphocytes production), meeting either of the following criteria:
- •CMV-seropositive donor (≥ 2 years of age)
- •CMV-seronegative related donor (≥ 18 years of age) who consents to receive the CMV vaccine
- •PATIENT CHARACTERISTICS:
- •ECOG performance status (PS) 0-3 OR Lansky PS 50-100% (for patients < 16 years of age)
- •Bilirubin < 2.0 mg/dL
- •AST and ALT < 2.5 times normal
- •Creatinine clearance ≥ 30 mL/min
- •Pulse oximetry ≥ 94% on no more than 40% oxygen by face mask
- •Not moribund
- •No patients expected to survive ≤ 1 month after the T-cell infusion due to cardiac, pulmonary, renal, hepatic, or neurologic dysfunction
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Must be on ≤ 1 mg/kg/day of prednisone or its equivalent at the time of study CTL infusion
排除标准
- 未提供
结局指标
主要结局
Safety
Toxicity
次要结局
- CMV DNA levels
- Time during post-infusion follow-up at which the dominant CMV pp65- and IE-1 epitopes for the donor is recognized by the cytotoxic T-cell lymphocytes (CTL)
- Time to development of cytomegalovirus (CMV)-specific immune reconstitution
- Feasibility of CMV pp65- and IE-1 CTL culture after CMV vaccination of seronegative donors
研究者
研究点 (1)
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