A phase I/II post cord blood HCT dendritic cells vaccination trial directed against WT1 for pediatric acute myeloid leukemia: the U-DANCE-anti-AML trial - U-DANCE-anti-AM

MC Utrecht0 个研究点目标入组 54 人开始时间: 2016年9月12日最近更新: 2024年3月12日

适应症

试验速览

暂无简介。

•-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) 52 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 (annex 1)
•-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
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 54
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Subject who meets any of the following criteria will be excluded from participation in this study:
•-Patients undergoing allo-HCT with stem cells derived from PBMCs or BM
•-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

发起方

MC Utrecht