CLINICAL TRIAL: SGN-40 (ANTI-HUCD40 MAB) IN RELAPSED DIFFUSE LARGE B-CELL LYMPHO

临床试验：SGN-40（抗 HUCD40 MAB）治疗复发性弥漫性大 B 细胞淋巴瘤

• 批准号: 7717926
• 负责人: RAJ ADVANI
• 金额: $ 1.44万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717926
• 关键词: Acetaminophen; B-Lymphocytes; Clinical; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Diffuse; Diphenhydramine; Disease Progression; Dose; Enrollment; Evaluable Disease; Exhibits; Funding; Grant; Image; In complete remission; Inflammatory; Infusion procedures; Institution; Label; PET/CT scan; Patients; Phase; Prednisone; Relapse; Research; Research Personnel; Resources; Safety; Schedule; Site; Source; Stable Disease; Symptoms; Testing; Time; Toxic effect; United States National Institutes of Health; Week; base; day; intravenous administration; large cell Diffuse non-Hodgkin' s lymphoma

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a phase II, open-label, multidose tiral to define the antitumor activity and the safety profile of single-agent SGN-40 in patients with relapsed DLBCL. Up to 35 evaluable patients will be enrolled at 6 to 10 US sites. 6-8 subjects will take part in this study at this institution. All patients in Cycle 1 will receive six intravenous (IV) infusions of SGN-40 over five weeks, using a previously tested dose-loading schedule. Patients will be premedicated with diphenhydramine and acetaminophen before each infusion. In addition, patients will be provided with and instructed to take a short course of prednisone if inflammatory symptoms develop after the infusion. Patients who meet criteria for clinical benefit may receive a second cycle of therapy beginning 14 days after the last dose. Patients who continue to exhibit clinical benefit after Cycle 2 may continue to receive additional therapy up to a total of six cycles of SGN-40. Cycles 3-6 must begin within 21 days of the last infusion of the previous cycle. Treatment may continue until disease progression is observed or two cycles beyond radiographically documented (CT and PET scan) complete response. Clinical benefit is defined as stable disease, partial resonse or complete response based on imaging studies and absence of significant unresolved toxicity at the time that the next cycle is scheduled to begin.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这是II期开放标签，多蛋白介质，用于定义复发DLBCL患者的抗肿瘤活性和单药SGN-40的安全性。 多达35名可评估的患者将在美国6至10个现场招收。 6-8名受试者将参加该机构的这项研究。 第1周期中的所有患者将使用先前测试的剂量加载时间表在五周内静脉注射（IV）输注SGN-40。 在每次输注之前，将用苯羟基胺和对乙酰氨基酚预处理患者。 此外，如果输注后炎症症状出现，将为患者提供并指示短暂的泼尼松。 符合临床益处标准的患者可能会在最后剂量后14天开始接受第二个治疗周期。 第2周期后继续表现出临床益处的患者可能会继续接受额外的治疗，总计六个周期为SGN-40。 循环3-6必须在上一个周期的最后一次输注后21天内开始。 治疗可能会持续到观察到疾病进展或两个循环超出射线照相记录（CT和PET扫描）的完全反应。 临床益处被定义为基于成像研究的稳定疾病，部分反应或完全反应，并且在安排下一个周期开始时缺乏明显的未解决的毒性。