Evaluation of Efficacy and Mechs of Topical Thalidomide for cGVHD Stomatitis

该研究的数据和安全监测计划得到了国家核研究中心数据和安全监测委员会的批准。2007年6月26日，FDA最终批准了沙利度胺外用凝胶IND 76,793的使用。招募于2007年11月开始，迄今为止在NIH临床中心招募了8名受试者。所有受试者均给予书面知情同意。收集了所有数据，并根据方案由受试者自行给药。受试者招募继续通过Richard Childs医学博士，国家心脏、肺和血液研究所副研究员，国家癌症研究所（NCI）每周在NIH临床中心赞助的cGVHD诊所，并通过全国招募工作进行。局部沙利度胺/安慰剂由美国国立卫生研究院临床中心药物开发服务处制备。

The data and safety monitoring plan for the study was approved by the NINR Data and Safety Monitoring Board. The FDA gave final clearance for use of thalidomide topical gel IND 76, 793, on June 26, 2007. Recruitment started in November 2007 with 8 subjects recruited to date at the NIH Clinical Center. All subjects gave written informed consent. All data was collected, and study drug self-administered by subject per protocol. Subjects recruitment continues through Richard Childs, MD, Associate Investigator, National Heart, Lung, and Blood Institute, the weekly National Cancer Institute (NCI) sponsored cGVHD Clinic at the NIH Clinical Center, and through a national recruitment effort. Topical thalidomide/placebo is prepared by the Pharmaceutical Development Service, Clinical Center, NIH.