Evaluation of Efficacy and Mechs of Topical Thalidomide for cGVHD Stomatitis

外用沙利度胺治疗cGVHD口腔炎的疗效及机制评价

• 批准号: 7594630
• 负责人: jane fall-dickson
• 金额: $ 16万
• 依托单位: NATIONAL INSTITUTE OF NURSING RESEARCH
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7594630
• 关键词: Age; Biological Factors; Blood; Clinic; Clinical; Clinical Services; Clinical Trials Data Monitoring Committees; Clinical assessments; Data; Development; Drug Formulations; Effectiveness; Gel; Heart; Inflammation; Inflammatory Response; Institutes; Lung; Monitor; Mouthwash; National Cancer Institute; Natural History; Oral Diagnosis; Outcome; Pathogenesis; Patients; Pharmacologic Substance; Placebos; Play; Population; Protocols documentation; Punch Biopsy; Purpose; Randomized Controlled Clinical Trials; Research Personnel; Role; Safety; Schedule; Stomatitis; Testing; Thalidomide; Topical application; Tumor Necrosis Factor-alpha; United States Food and Drug Administration; United States National Institutes of Health; chronic graft versus host disease; clinical efficacy; cytokine; efficacy evaluation; human TNF protein; inclusion criteria; novel; oral condition; prospective; tool

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.

这项研究的数据和安全监测计划已经得到NINR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局部凝胶IND 76,793的使用。招聘计划于2007年10月在NIH临床中心开始。除了国家心脏、肺和血液研究所副研究员、医学博士Richard Childs提供的患者群体外，cGVHD患者还将通过国家癌症研究所(NCI)赞助的位于NIH临床中心的每周cGVHD诊所进行转介，该诊所由NCI赞助的cGVHD自然病史方案“决定cGVHD患者预后的临床和生物因素的前瞻性评估”(04-C-0281)主持。外用沙利度胺由美国国立卫生研究院临床中心药物开发服务处准备。