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

这是一项单臂、开放标签、多中心的研究，碘-131抗b1抗体用于治疗非霍奇金淋巴瘤（NHL）患者，这些患者之前接受过利妥昔单抗治疗。在这项研究中，40名患者将接受研究药物。患者必须接受过至少4次剂量的利妥昔单抗治疗，并且在后续的利妥昔单抗治疗期间出现进展。患者将经历两个阶段的研究。在第一阶段，称为“剂量学剂量”，患者将接受未标记的抗b1抗体（450毫克）输注超过70分钟（包括10分钟的冲洗），紧接着是30分钟的抗b1抗体（35毫克）输注（包括10分钟的冲洗），该抗体已用5mci的碘-131放射标记。在剂量学剂量后的第0天、第2天、第3天或第4天以及第6天或第7天进行全身伽玛相机扫描。使用来自三个成像时间点的剂量学数据，将计算出提供所需全身放射治疗剂量的碘-131患者特异性剂量。在第二阶段，称为“治疗剂量”，患者将接受70分钟的未标记的抗b1抗体（450毫克）输注（包括10分钟的冲洗），紧接着是30分钟的35毫克标记有患者特异性剂量的碘-131的抗b1抗体输注（包括10分钟的冲洗），向无血液学危险因素的患者输送75 cGy的全身剂量。基线血小板计数为100,001 - 149,999细胞/mm3的患者将接受65 cGy，肥胖患者将根据其瘦体重的137%给药。病人将得到治疗；在首次输注碘-131抗b1抗体（即剂量计剂量）前至少24小时开始，并在最后一次输注碘-131抗b1抗体（即治疗剂量）后持续14天，使用饱和碘化钾溶液（SSKI）、卢戈尔溶液或碘化钾片。该研究的终点是确定先前接受过利妥昔单抗治疗的NHL患者的碘-131抗b1抗体治疗的缓解率、完全缓解率、缓解持续时间、进展时间、治疗失败时间、安全性和生存率。

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.