NL-OMON36436已完成2 期
TREATMENT WITH CMV PP65 SPECIFIC T CELLS GENERATED BY USE OF A CMV PP65 PROTEIN-SPANNING PEPTIDE POOL IN PATIENTS WITH CMV REACTIVATION OR CMV DISEASE AFTER ALLOGENEIC STEM CELL TRANSPLANTATION - CMV pp65 specific T cells
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 99(—)
入选标准
- •* age 0-75 year
- •* recipient of alloSCT for standard indication according to national- and European Group for blood and Marrow Transplantation-guidelines (see appendix D)
- •* Possibility to obtain PBMC by leukapheresis from the CMVseropositive donor or availability of peripheral blood stem cell graft (PBSCT) or of a CD34-negative subfraction of a CD34-positively selected PBSCT product of the donor prepared and cryopreserved at a GMP-facility or stem cell center.
- •* CMV reactivation treatment failure (persistent CMV DNA load of more than 1000 cp/ml or CMV disease after 2 weeks of adequate treatment with antiviral therapy or relapse of CMV DNA load of more than 1000 cp/ml within 4 weeks after adequate treatment with antiviral therapy or contraindication for treatment with antiviral therapy at the discretion of the physician) or CMV disease (organ dysfunction (pneumonitis, enteritis, retinitis, encephalitis, hepatitis, and bone marrow suppression) due to CMV infection).
- •* Written informed consent by the patient and/or parent(s) or legal guardian(s).
排除标准
- •- Life expectation < 3 months.
- •- End stage irreversible multi-system organ failure.
- •- Pregnant or lactating women.
- •- Severe psychological disturbances.
- •- Patient HIV positive.
- •- Donor HIV positive.
研究者
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