PHASE II STUDY OF BEXXAR IN RELAPSED/REFRACTORY DLCL

BEXXAR 治疗复发/难治性 DLCL 的 II 期研究

• 批准号: 7375291
• 负责人: Susan J. Knox
• 金额: $ 0.18万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7375291
• 关键词: PHASE; II; STUDY; BEXXAR; RELAPSED

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 single institution Phase II study to determine the efficacy and safety of Bexxar (Tositumomab anti-CD20 monoclonal antibody and 131I-Tositumomab) in patients with relapsed/refractory Diffuse Large Cell non-Hodgkin's Lymphoma (DLCL). A course of therapy will consist of an initial dosimetric/biodistribution study utilizing 450 mg Tositumomab IV (to optimize biodistribution) followed by 5 mCi 131I on 35 mg of tositumamb IV, with gamma camera imaging of patients at 3 time points over 7 days for purposes of calculating a patient-specific dose/activity of 131I-Tositumomab calculated to deliver a whole body absorbed dose of 75 cGy for patients with platelet counts >= 150,000 and 65 cGy for patients with platelet counts >= 100,000, but < 150,000. The therapeutic dose of 131I-Tositumomab will be given on 35 mg of Tositumomab and preceded by infusion of 450 mg tositumomab 7 days following administration of the dosimetric dose. This is the standard methodology (dose and schedule) for administration of Bexxar as approved by the FDA for the treatment of patients with low grade and transformed B-cell NHL.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。这是一项确定Bexxar（Tositumomab抗CD 20单克隆抗体和131 I-Tositumomab）在复发性/难治性弥漫性大细胞非霍奇金淋巴瘤（DLCL）患者中的疗效和安全性的单机构II期研究。一个疗程将包括使用450 mg托西莫单抗IV的初始剂量测定/生物分布研究（以优化生物分布），然后在35 mg托西莫单抗IV上注射5 mCi 131 I，在7天内的3个时间点对患者进行伽马照相机成像，以计算131 I的患者特异性剂量/活度-血小板计数≥ 150，000的患者，托西莫单抗的全身吸收剂量为75 cGy;血小板计数≥ 100，000但<150，000的患者，托西莫单抗的全身吸收剂量为65 cGy。治疗剂量的131 I-托西莫单抗将在35 mg托西莫单抗的基础上给药，并在剂量测定剂量给药后7天输注450 mg托西莫单抗。这是FDA批准用于治疗低级别和转化B细胞NHL患者的Bexxar给药的标准方法（剂量和时间表）。