RETREATMENT OF NON HODGKINS LYMPHOMA W/ IODINE 131 ANTI B1 ANTIBODY

这是一项单臂、开放标签、多中心研究，目的是研究碘-131抗B1抗体治疗非霍奇金淋巴瘤(NHL)患者的疗效，这些患者以前对碘-131抗B1抗体治疗有反应(PR、CCR或CR)，持续时间至少3个月。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，患者将接受70分钟(包括10分钟冲洗)的未标记的抗-B1抗体(450毫克)的注射，然后立即注射30分钟(包括10分钟的冲洗)抗-B1抗体(35毫克)，该抗体已经被放射性标记为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天进行。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分钟冲刷)未标记的抗-B1抗体(450毫克)的输注，然后30分钟(包括10分钟的冲刷)注射35毫克的标记有患者特定剂量的碘-131的抗-B1抗体，以提供所需的全身放射剂量。对于基线血小板计数等于或大于150,000个细胞/毫米的患者，如果他们之前没有接受过骨髓或干细胞移植，全身辐射剂量将为75cGy.对于基线血小板计数在100,001-149,999个/mm的患者，如果他们之前没有接受过骨髓或干细胞移植，全身放射剂量将为65cGy.对于基线血小板=150,000个/毫米、以前接受过骨髓或干细胞移植的患者，全身辐射剂量将为55cGy.对于基线血小板计数在100,001-149,999个/mm并曾接受过骨髓或干细胞移植的患者，全身辐射剂量将为45cGy.对于过度肥胖的患者(体重超过其瘦体重的137%的患者)，将使用基于身高和性别的质量上限(最大有效质量)进行计算，以确定要实施的碘-131抗体活性。患者将在第一次注射碘-131抗-B1抗体(即剂量剂量)前至少24小时开始接受饱和溶液碘化钾(Sski)、卢戈尔溶液或碘化钾片剂治疗，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对碘-131抗体治疗有反应(PR、CCR、CR)至少3个月的NHL患者在碘-131抗体治疗后的应答率、完全应答率、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 if Iodine-131 Anti-B1 Antibody for the treatment of patients with non-Hodgkin's lymphoma (NHL) who previously responded (PR, CCR, or CR) with a duration of response of at least 3 months to Iodine-131 Anti-B1 Antibody 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 the desired whole body dose of radiation. The whole body radiation dose will be 75cGy for patients with a baseline platelet count equal to/greater than 150,000 cells/mm who have not undergone prior bone marrow or stem cell transplant. The whole body radiation dose will be 65 cGy for patients with a baseline platelet count of 100,001 - 149,999 cells/mm who have not undergone prior bone marrow or stem cell transplant. The whole body radiation dose will be 55 cGy for patients with a baseline platelet =150,000 cells/mm who have previously undergone bone marrow or stem cell transplant. The whole body radiation dose will be 45 cGy for patients who have a baseline platelet count of 100,001 - 149,999 cells/mm and have previously undergone bone marrow or stem cell transplant. For excessively obese patients (patients weighing more than 137% of their lean body mass), the calculations to determine Iodine-131 Anti-B1 Antibody activity to administer will be performed using an upper limit of mass (maximum effective mass) based upon height and gender. Patients will be treated with either 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., 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 following Iodine-131Anti-B1 Antibody therapy in patients with NHL who have previously responded (PR, CCR, CR) with a duration of response of at least 3 months to Iodine-131 Anti-B1 Antibody therapy.