PHASE II STUDY OF IODINE 131 ANTI BI ANTIBODY FOR NON HODGKINS LYMPHOMA

这是一项针对碘-131抗B1抗体的单臂、开放标记、多中心研究，用于治疗以前接受利妥昔单抗治疗的非霍奇金淋巴瘤(NHL)患者。40名患者将在这项研究中接受研究药物。患者必须至少接受过四剂利妥昔单抗治疗，并且在随后的利妥昔单抗治疗期间病情有所进展。患者将经历两个阶段的研究。在被称为“剂量剂量”的第一阶段中，患者将在70分钟内(包括10分钟的冲洗)注射未标记的抗-B1抗体(450毫克)，然后立即注射30分钟(包括10分钟的冲洗)，该抗体(35毫克)已被放射性标记为5mCI的碘-131。全身伽马相机扫描将在剂量测量后的第0天、第2天、第3天或第4天以及第6天或第7天获得。使用三个成像时间点的剂量学数据，将计算出患者特定剂量的碘-131，以提供所需的放射治疗总剂量。在第二阶段，称为“治疗剂量”，患者将立即接受70分钟(包括10分钟冲洗)未标记的抗-B1抗体(450毫克)的输注，然后30分钟(包括10分钟的冲洗)注射35毫克标记了患者特定剂量的碘-131的抗-B1抗体，以向没有血液病危险因素的患者提供75cGy全身剂量。基线血小板计数在100,001-149,999个/mm3的患者将接受65cGy射线治疗，肥胖患者将根据其瘦体重的137%接受剂量。患者将接受治疗；使用饱和溶液碘化钾(SKI)、卢戈尔溶液或碘化钾片剂，从第一次注射碘-131抗B1抗体(即剂量剂量)前至少24小时开始，并在最后一次注射碘-131抗B1抗体(即治疗剂量)后持续14天。这项研究的目的是确定碘-131抗体治疗NHL患者的有效率、完全有效率、有效持续时间、进展时间、治疗失败时间、安全性和存活率。

This is a single-arm, open-label, multicenter study of Iodine-131 Anti-B1 Antibody for the treatment of non-Hodgkin's lymphoma (NHL) patients who were previously treated with rituximab antibody. Forty patients will receive study drug on this study. Patients must have been treated with at least four doses of rituximab and have progressed during of following rituximab therapy. Patients will undergo two phases of study. In the first phase, termed the "dosimetric dose", patients will receive an infusion of unlabeled Anti-B1 Antibody (450 mg) over 70 minutes (including a 10-minute flush) immediately followed by a 30-minute infusion (including a 10-minute flush) of Anti-B1 Antibody (35 mg) which has been radiolabeled with 5 mCi of Iodine-131. Whole body gamma camera scans will be obtained on Day 0, Day 2, 3 or 4, and Day 6 or 7 following the dosimetric dose. Using the dosimetric data from the three imaging timepoints, a patient-specific dose of Iodine-131 to deliver the desired total body dose of radiotherapy will be calculated. In the second phase, termed the "therapeutic dose", patients will receive a 70-minute infusion (including a 10-minute flush) of unlabeled Anti-B1 Antibody (450 mg) immediately followed by a 30-minute infusion (including a 10-minute flush) of 35 mg Anti-B1 Antibody labeled with the patient-specific dose of Iodine-131 to deliver a whole body does of 75 cGy to patients with no hematologic risk factors. Patients who have baseline platelet counts of 100,001 - 149,999 cells/mm3 will receive 65 cGy and patients who are obese will be dosed based upon 137% of their lean body mass. Patients will be treated ;with saturated solution potassium iodide (SSKI), Lugol's solution, or potassium iodide tablets, starting at least 24 hours prior to the first infusion of the Iodine-131 Anti-B1 Antibody (i.e., the dosimetric dose) and continuing for 14 days following the last infusion of Iodine-131 Anti-B1 Antibody (i.e., the therapeutic dose). The endpoints of the study are to determine the response rate, complete response rate, duration of response, time to progression, time to treatment failure, safety, and survival of Iodine-131 Anti-B1 Antibody therapy in NHL patients who have previously been treated with rituximab.