Plasma Biomarkers of Acute Graft Versus Host Disease

描述（由申请人提供）：急性移植物抗宿主病（GVHD）是同种异体造血细胞移植（HCT）的主要局限性。目前还没有可靠的诊断测试来预测治疗结果，这与长期生存有关。我们最近评估了六种先前验证的GVHD诊断生物标志物(IL2R？、TNFR1、HGF、IL8、elafin和REG3？，因为他们能够预测哪些患者对治疗有反应，哪些患者能够长期生存。我们通过对112名参加新诊断急性GVHD的多中心随机II期临床试验的患者在治疗开始时和治疗后28天前瞻性获得的样本测量生物标志物浓度。我们发现了一种算法，使用所有六种生物标志物的值来预测发病后第28天对治疗的反应和第180天的死亡率。该项目将通过测量第二组200名患者的所有六种生物标志物来验证该算法，这些患者最近参加了一项针对新诊断的急性GVHD的多中心随机II期临床试验。Awe还将开发一种新的算法，包括第七种生物标志物，也可以预测对GVHD治疗的反应。该算法将包括开始治疗后第28天对治疗的反应以及开始治疗后第180天的死亡率。

DESCRIPTION (provided by applicant): Acute graft-versus-host disease (GVHD) is the primary limitation of allogeneic hematopoietic cell transplantation (HCT). There are currently no reliable diagnostic tests to predict the outcome of treatment, which correlate to long term survival. We have recently evaluated six previously validated diagnostic biomarkers of GVHD (IL2R?, TNFR1, HGF, IL8, elafin, and REG3?, for their ability to predict which patients would respond to therapy and who would achieve long term survival. We measured biomarker concentrations by from samples prospectively obtained at the initiation of treatment and day 28 following treatment in 112 patients who participated in a multicenter, randomized phase II clinical trial for newly diagnosed acute GVHD. We discovered an algorithm using values from all six biomarkers that predicted both day 28 response to treatment and mortality at day 180 from onset. This project will validate that algorithm by measuring all six biomarkers in a second group of 200 patients who patients who have recently participated in a multicenter, randomized phase II clinical trial for newly diagnosed acute GVHD. Awe will also develop a new algorithm by including a seventh biomarker that also predicts for response to treatment for GVHD. This algorithm will include both responses to treatment on day 28 after initiation of treatment as well as mortality at day 180 from the initiation of treatment.