EUCTR2021-005150-28-IT招募中1 期
Virus-specific T-cell Immunity for the Treatment of Some Resistant Viral Infections After Allogeneic Hematopoietic Stem Cell Transplantation(HSCT) - Adoptive T-cell Therapy for Resistant Viral Infections After Allogeneic HSCT ( VS-TC )
IRCCS ISTITUTO GIANNINA GASLINI0 个研究点目标入组 10 人开始时间: 2022年1月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
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
- 性别
- All
入选标准
- •Allogeneic transplant with any cells source and conditioning regimen
- •Age between 0-21 years
- •Viral infection/reactivation (CMV, EBV, ADV)
- •Resistance of viral infections to treatments
- •Absence of concomitant severe uncontrolled infections
- •Life expectancy exceeding 30 days
- •Absence of acute or chronic uncontrolled Graft versus Host Disease
- •Absence of acute kidney damage (creatinine value> 3 times the value
- •normal with respect to age) not related to viral infection;
- •Absence of severe acute liver injury (direct bilirubin> 3mg / dl or glutamicoxaloacetic
- •transaminase -SGOT> 500 UI/L) not related to viral infection;
- •Presence of informed consent to the treatment of the patient / parent /legal
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 3
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Absence of a suitable donor (seronegativity for the virus in question and /
- •or failure to respond to the secretion test)
- •Patient with severe renal and/or hepatic impairment as specified above
- •Primary or secondary graft failure
- •Relapse of malignant underlying disease
研究者
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