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: 7735236
• 负责人: jane fall-dickson
• 金额: $ 19.94万
• 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/7735236
• 关键词: Age; Blood; Clinic; Clinical; Clinical Services; Clinical Trials Data Monitoring Committees; Data; Development; Drug Formulations; Effectiveness; Gel; Heart; Inflammation; Inflammatory Response; Informed Consent; Institutes; Lung; Monitor; Mouthwash; National Cancer Institute; Oral Diagnosis; Oral mucous membrane structure; Pathogenesis; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Placebos; Play; Protocols documentation; Punch Biopsy; Purpose; Randomized Controlled Clinical Trials; Recruitment Activity; Research Personnel; Role; Safety; Self-Administered; Stomatitis; Testing; Thalidomide; Topical application; Tumor Necrosis Factor-alpha; United States Food and Drug Administration; United States National Institutes of Health; Writing; chronic graft versus host disease; clinical efficacy; cytokine; efficacy evaluation; human TNF protein; inclusion criteria; novel; oral condition; tool

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.

本研究的数据和安全性监查计划由NINR数据和安全性监查委员会批准。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。所有受试者均提供了书面知情同意书。收集所有数据，并由受试者按照方案自行给予研究药物。受试者招募继续通过Richard查尔兹，MD，国家心脏，肺和血液研究所的副研究员，国家癌症研究所（NCI）每周赞助的NIH临床中心的cGVHD诊所，并通过全国招募工作。局部沙利度胺/安慰剂由NIH临床中心药物开发服务部制备。