EUCTR2015-003554-41-NL进行中（未招募）1 期
A phase I/II minor histocompatibility antigen UTA2-1 loaded, PD-L silenced Dendritic cell vaccination trial after allogeneic Stem Cell Transplantation to improve the safety and efficacy of Donor Lymphocyte Infusions. - minor H ag UTA2-1 loaded PD-L silenced DC vaccination for hematological cancers
VU University Medical Center0 个研究点目标入组 12 人开始时间: 2015年11月19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
- 12
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. Patients with Multiple Myeloma (MM), Chronic Lymphocytic Leukemia (CLL), non hodgkin lymphoma (any grade), Hodgkin’s lymphoma (HL),
- •2. Proven residual disease (including as determined by disease-specific or patient-specific PCR) minimally 6 months after allogeneic Stem Cell Transplantation (allo-SCT) and subsequent persistent or relapsed disease after a first therapeutic DLI
- •3. Recipient and donor have a mismatch in UTA2-1 mHag in the Graft versus Tumor (GvT) direction (recipient UTA2-1 positive, donor UTA2-1 negative).
- •4. Recipient and donor are positive for HLA-A*0201
- •5. Age 18-75 years
- •6. Absence of acute GvHD > grade 1 or extensive chronic GvHD
- •7. No treatment with immunosuppressive drugs such as prednisone, cyclosporine A and MMF at least 8 weeks prior to planned vaccination date.
- •8. WHO performance 0-2
- •9. Absence of severe cardiac hepatic, renal, or metabolic disease
- •10. Written informed consent
- •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 8
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1. WHO performance 3-4
- •2. Presence of severe cardiac hepatic, renal, metabolic disease
- •3. Rapidly progressive disease, despite reinduction therapy
- •4. Life expectancy < 3 months
研究者
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