EUCTR2012-003033-42-DE进行中（未招募）1 期
Prospective, open-label, multicentre clinical trial, phase I/IIa, to investigate the safety and tolerability of allogeneic B-cell concentrates CD3+-depleted, CD19+-enriched, cryopreserved (single administration after day 120 following allogeneic stem cell transplantation, donor-identical) in 4 groups with escalating doses for immune response enhancement, measured as response to a preponed single vaccination - B-cell therapy trial
niversitätsklinikum Erlangen0 个研究点目标入组 15 人开始时间: 2013年2月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or female person aged 18 to 75 years.
- •2.Written informed consent of the patient.
- •3.Day 100±10 days after allogeneic stem cell transplantation.
- •4.Serostatus for EBV: R-/D- oder R+/D- oder R+/D+.
- •7.Females must in addition meet at least one of the following criteria:
- •menopause (minimum amenorrhoea for 12 months oder amenorrhoea for 6 Monate with serum FSH >40mU/ml) or bilateral ovarectomy or hysterectomy or vasectomy of her partner (all in medical history) or routine, correct and consequent use of a contraceptual method with a failure rate of <1%/year.
- •Are the trial subjects under 18? no
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1.Serostatus for EBV: R-/D+.
- •2.Severe acute GvHD (Glucksberg grade III und IV).
- •3.Chronic GvHD in middle- or high-risk group according to NIH staging.
- •4.Rituximab administration after SCT.
- •5.>10.000 EBV DNA copies/ml plasma.
- •6.Recurrence of the haematological disorder needing therapeutic intervention.
- •7.Secondary transplantation.
- •8.SCT with transplat from a haploidentical donor.
- •9.SCT with transplant from umbilical cord blood.
- •10.CD34+-enriched transplant.
- •11.in vitro T-cell depleted transplant.
- •12.Pregnant or breast-feeding female.
研究者
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