NL-OMON44046撤回2 期
A phase I/II post-cord blood HCT dendritic cell vaccination trial directed against WT1 for pediatric acute myeloid leukemia: the U-DANCE-anti-AML trial - U-DANCE-anti-AM
niversitair Medisch Centrum Utrecht0 个研究点目标入组 54 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 54
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 17（—）
入选标准
- •-Pediatric AML patients eligible for allo-HCT according to standard-of-care guidelines, with overexpression of WT1 mRNA in an AML sample (>50 copies WT1/10^4 copies ABL for PB, and >250 copies WT1/10^4 copies ABL for BM) taken at diagnosis and/or relapse after (re-)induction chemotherapy.;-Indication for CB-HCT according to the UMC Utrecht guidelines;-CB selection criteria: the 80% fraction of the unit should contain a minimum total nucleated cell number of 3x10^7 NC/Kg criteria for any match grade (before cryo-preservation). Preferable CD34+/Kg dose: > 1x10e5 in the 80% fraction;-The whole CB unit should contain more than 7.5x10^6 total CD34+ before freeze.;-Karnofsky/Lansky score *70 ;-Age limits for part A (safety run) only: *12 and *17 years of age, and <18 years for part B of the study. ;-Signed informed consent
排除标准
- •- Patients undergoing allo-HCT with stem cells derived from PBMCs or bone marrow;- Patients who are pregnant or breast-feeding or unwilling to use adequate contraceptive methods;- Known allergies to compounds used in the CBDC production process or the local anesthetic Lidocaine-tetracaine (Rapydan®) plasters;- Patients included in other intervention studies influencing the endpoints of this study
研究者
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