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

这是一项单组、开放标签、多中心研究，研究碘-131抗B1抗体治疗既往对碘-131抗B1抗体治疗有应答（PR、CCR或CR）且应答持续时间至少3个月的非霍奇金淋巴瘤（NHL）患者。 患者将接受两个阶段的研究。 在第一阶段，称为“剂量测定剂量”，患者将在70分钟内接受未标记抗B1抗体（450 mg）输注（包括10分钟冲洗），随后立即接受30分钟（包括10分钟冲洗）抗B1抗体（35 mg）输注（已用5 mCi碘-131进行放射性标记）。 将在剂量测定剂量后第0天、第2、3或4天以及第6或7天进行全身伽马相机扫描。 使用来自三个成像时间点的剂量测定数据，将计算输送所需放疗全身剂量的碘-131的患者特定剂量。 在第二阶段，称为“治疗剂量”，患者将接受未标记抗B1抗体（450 mg）70分钟输注（包括10分钟冲洗），随后立即接受35 mg抗B1抗体30分钟输注（包括10分钟冲洗），用患者特定剂量的碘-131标记，以递送所需的全身剂量的辐射。 对于基线血小板计数等于/大于150，000个细胞/mm 2且既往未接受过骨髓或干细胞移植的患者，全身再辐射剂量为75 cGy。 对于基线血小板计数为100，001 - 149，999个细胞/mm 2且既往未接受骨髓或干细胞移植的患者，全身辐射剂量为65 cGy。对于基线血小板≥ 150，000个细胞/mm 2且既往接受过骨髓或干细胞移植的患者，全身辐射剂量为55 cGy。 对于基线血小板计数为100，001 - 149，999个细胞/mm 2且既往接受过骨髓或干细胞移植的患者，全身辐射剂量为45 cGy。 对于过度肥胖患者（体重超过其瘦体重的137%的患者），将使用基于身高和性别的体重上限（最大有效体重）进行计算，以确定给予的碘-131抗B1抗体活性（见附录A表1）。 患者将在首次输注碘-131抗B1抗体前至少24小时开始接受饱和碘化钾溶液（SSKI）、Lugol溶液或碘化钾片剂治疗（即，剂量测定剂量）并在最后一次输注碘-131抗B1抗体后持续14天（即，该研究的终点是确定碘-131抗B1抗体疗法在患有NHL的患者中的响应率、完全响应率、响应持续时间、进展时间、治疗失败时间、安全性和存活，所述患者先前对碘-131抗B1抗体疗法有响应（PR、CCR、CR），响应持续时间为至少3个月。

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 (indluding 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 readiation 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 vount 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 (see Table 1, APPENDIX A). 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-131 Anti-B1 Antibody therapy in patients wih 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.