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: 8554725
• 负责人: Leorey Saligan
• 金额: $ 2.09万
• 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/8554725
• 关键词: Age; Clinical; Clinical Services; Clinical Trials Data Monitoring Committees; Data; Data Analyses; Dental; Development; Drug Formulations; Effectiveness; Enrollment; Exudate; Fred Hutchinson Cancer Research Center; Gel; Inflammation; Inflammatory Response; Informed Consent; Institutes; Institutional Review Boards; Manuscripts; Monitor; Mouth Diseases; National Institute of Dental and Craniofacial Research; Nursing Research; Oral; Oral Diagnosis; Oral Ulcer; Oral mucous membrane structure; Oropharyngeal; Pain; Pathogenesis; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Placebos; Plasma; Play; Principal Investigator; Protocols documentation; Punch Biopsy; Randomized Controlled Clinical Trials; Research; Role; Safety; Saliva; Self-Administered; Site; Stomatitis; Testing; Thalidomide; Topical application; Tumor Necrosis Factor-alpha; United States National Institutes of Health; Visit; Writing; chronic graft versus host disease; clinical efficacy; clinical research site; cytokine; efficacy evaluation; inclusion criteria; novel; oral condition; tool; treatment strategy

The FDA gave final clearance for use of thalidomide topical gel IND 76, 793, on June 26, 2007. Subject recruitment started in November 2007 at the Clinical Center, NIH. All subjects gave written informed consent. All data were collected, and study drug self-administered by subjects per protocol. Topical thalidomide and placebo was prepared by the Pharmaceutical Development Service, Clinical Center, NIH. The Fred Hutchinson Cancer Research Center's (FHCRC), Seattle, WA., institutional review board approved the protocol in August, 2008. Following the site initiation visit conducted by the principal investigator and senior research nurse in January 2009, the FHCRC was added as the second clinical site for this protocol. Subject accrual was slower than anticipated with 10 subjects enrolled at the Clincal Center, NIH, over 2 years, and no subjects enrolled at the FHCRC over 1 year. Therefore, the study was closed to subject accrual with data analyses ongoing with National Institute of Dental and Cranifacial Research Institutional Review Board, NIH, approval. Data analysis examined preliminary findings of topical thalidomide gel on oral ulcerative chronic GVHD, levels of proinflammatory cytokines in saliva, oral ulcer exudate, and plasma, as well as oropharyngeal pain.

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。受试者招募于 2007 年 11 月在 NIH 临床中心开始。所有受试者均签署了书面知情同意书。收集所有数据，并根据方案由受试者自行施用研究药物。外用沙利度胺和安慰剂由 NIH 临床中心药物开发服务处制备。位于华盛顿州西雅图的 Fred Hutchinson 癌症研究中心 (FHCRC) 的机构审查委员会于 2008 年 8 月批准了该方案。继 2009 年 1 月首席研究员和高级研究护士进行现场启动访问后，FHCRC 被添加为该方案的第二个临床中心。受试者招募速度比预期慢，NIH 临床中心有 10 名受试者入组超过 2 年，而 FHCRC 没有受试者入组超过 1 年。因此，该研究已结束受试者累积，数据分析正在进行中，并得到美国国立卫生研究院国家牙科和颅面研究机构审查委员会的批准。数据分析检查了外用沙利度胺凝胶对口腔溃疡慢性 GVHD、唾液、口腔溃疡渗出物和血浆中促炎细胞因子水平以及口咽疼痛的初步结果。