NL-OMON37500已完成2 期
A phase I/II *minor histocompatibility antigen (mHag)-based Dendritic cell (DC) vaccination trial after allogeneic Stem Cell Transplantation (allo-SCT) to improve the safety and efficacy of donor lymphocyte infusions. - mHag donor DC vaccination in haematological malignancy
niversitair Medisch Centrum Utrecht0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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
- 18 至 99（—）
入选标准
- •1.Patient with a measurable persistent disease after preceding DLI given for persistent or relapsed malignancy after allo-SCT. Reinduction chemotherapy in case of rapidly progressive disease (e.g. in AML) is allowed.
- •2. Recipient and donor with at least one relevant mismatch in mHags HA-1, HA-2, ACC1, ACC2, PANE1, LRH-1, CD19L or HB-1 in the Graft versus Tumor (GvT) direction (recipient mHag positive, donor mHag negative).
- •3. Recipient and donor positive for the relevant HLA, presenting the mismatched mHag(s).
- •4. Expression of the mismatched mHag in the lineage from which the malignancy has arisen.
- •5. Age 18-70 years
- •6. Absence of acute GvHD > grade 1 or extensive chronic GvHD
- •7. No prior or concomitant treatment for 8 weeks with immunosuppressive drugs such as prednisone, cyclosporine A and MMF.
- •8. WHO performance 0-2 (see appendix 1)
- •9. Absence of severe cardiac hepatic, renal, or metabolic disease
- •10. Written informed consent
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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