PHASE II STUDY OF BEXXAR IN RELAPSED/REFRACTORY DLCL

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这是一项单一机构的II期研究，旨在确定Bexxar(Tositumomab抗CD20单抗和131I-Tositumomab)治疗复发/难治性弥漫性大细胞非霍奇金淋巴瘤(DLCL)的疗效和安全性。一个疗程的治疗将包括使用450毫克Tositumomab IV(以优化生物分布)的初始剂量学/生物分布研究，然后使用35 mg Tositumamb IV的5 mCI 131I，在7天内的3个时间点对患者进行伽马相机成像，以计算患者特定剂量/活性131I-Tositumomab，计算得出血小板计数&Gt；=150,000的患者全身吸收剂量为75 cGY，血小板计数&Gt；=100,000的患者为65 cGy.治疗剂量131I-Tositumomab将在35 mg Tositumomab的基础上给予，然后在给药剂量后7天静脉滴注450 mg Tositumomab。这是FDA批准的治疗低级别和转化的B细胞NHL患者使用Bexxar的标准方法(剂量和时间表)。

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.