PHASE II STUDY OF BEXXAR IN RELAPSED/REFRACTORY DLCL

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这是一项单机构II期研究，旨在确定Bexxar （Tositumomab抗cd20单克隆抗体和131I-Tositumomab）治疗复发/难治性弥漫性大细胞非霍奇金淋巴瘤（dcl）患者的疗效和安全性。一个疗程将包括初始剂量学/生物分布研究，使用450mg tositumumab IV（以优化生物分布），然后使用35mg tositumumab IV进行5mci 131I。对患者在7天内的3个时间点进行伽玛相机成像，计算131i - tositumumab的患者特异性剂量/活性，对于血小板计数>= 150,000的患者计算出75 cGy的全身吸收剂量，对于血小板计数>= 100,000但< 150,000的患者计算出65 cGy的全身吸收剂量。131I-Tositumomab的治疗剂量将给予35 mg Tositumomab，并在给药剂量后7天输注450 mg Tositumomab。这是FDA批准的用于治疗低级别转化b细胞NHL患者的Bexxar管理的标准方法（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.