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

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这是一项II期、开放标签、多次给药试验，旨在确定SGN-40单药治疗复发性DLBCL患者的抗肿瘤活性和安全性特征。 将在6 - 10家美国临床试验机构入组最多35例可评价患者。 6-8受试者将在该机构参加本研究。 第1周期的所有患者将在5周内接受6次SGN-40静脉（IV）输注，使用先前测试的剂量负荷方案。 每次输注前，患者将接受苯海拉明和对乙酰氨基酚的术前用药。 此外，如果输注后出现炎症症状，将为患者提供并指导其接受短期泼尼松治疗。 符合临床获益标准的患者可在末次给药后14天开始接受第二个周期的治疗。 在第2周期后继续表现出临床获益的患者可继续接受额外治疗，最多共6个周期的SGN-40治疗。 第3-6周期必须在前一周期末次输注后21天内开始。 治疗可持续至观察到疾病进展或超过放射学记录（CT和PET扫描）完全缓解两个周期。 临床获益定义为基于影像学研究的疾病稳定、部分缓解或完全缓解，并且在计划的下一个周期开始时不存在显著的未消退毒性。

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.