Evaluation of Efficacy and Mechs of Topical Thalidomide for cGVHD Stomatitis

本研究的数据和安全性监查计划已获得NINR数据和安全性监查委员会的批准。FDA于2007年6月26日最终批准使用沙利度胺外用凝胶IND 76，793。招募计划于2007年10月在NIH临床中心开始。除了由Richard查尔兹，MD，国家心肺和血液研究所副研究员提供的患者人群外，cGVHD患者将通过NIH临床中心的每周国家癌症研究所（NCI）赞助的cGVHD诊所转诊，在NCI-sponsored cGVHD自然史方案“cGVHD患者临床和生物学因素决定结局的前瞻性评估”的支持下，（04-C-0281）。局部沙利度胺由NIH临床中心药物开发服务处制备。

The data and safety monitoring plan for the study has been 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 is scheduled to start October 2007 at the NIH Clinical Center. In addition to the patient population provided by Richard Childs, MD, Associate Investigator, National Heart, Lung, and Blood Institute, cGVHD patients will be referred through the weekly National Cancer Institute (NCI) sponsored cGVHD Clinic at the NIH Clinical Center, under the auspices of the NCI-sponsored cGVHD natural history protocol "Prospective Assessment of Clinical and Biological Factors Determining Outcomes in Patients with cGVHD" (04-C-0281). Topical thalidomide is prepared by the Pharmaceutical Development Service, Clinical Center, NIH.