NL-OMON55718尚未招募2 期
A phase I/II post-cord blood HCT dendritic cell vaccination trial directed against WT1 for pediatric and young adult acute myeloid leukemia: the U-DANCE-anti-AML-trial - U-DANCE-anti-AM
Prinses Máxima Centrum voor Kinderoncologie0 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
- 尚未招募
- 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
- 0 至 64（—）
入选标准
- •- 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 (re-)induction chemotherapy.
- •- indication for CB-HCT according to the Prinses Maxima Centrum / UMC Utrecht
- •- CB selection criteria: the 80% fraction of the unit should contain a minimum
- •total nucleatd 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 - <=30 years of age (first thee
- •patients >16 years of age), part B 0- <=30 years of age
排除标准
- •-Patients who are preganant or breast-feeding or unwilling to use adequate
- •contraceptive methods
- •-Known allergies to compound used in the CBDC production process or the local
- •anesthetic lidocaïne-tetracain (Rapydan®) and EMLA® (lidocaine/ prilocaine)
- •-Patients included in other intervention studies influencing the endpoints of
研究者
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