ANTI-B1 (MURINE) IN CHEMOTHERAPY-REFRACTORY LOW GRADE NONHODGKIN'S LYMPHOMA

这是一项多中心前瞻性随机研究， 抗B1 RIT和未标记抗B1单克隆抗体治疗 化疗难治性低级别B细胞淋巴瘤患者。的 本研究的目的是评估增量临床活动 放射性标记鼠抗CD 20单克隆抗体的毒性 （抗B1）与131碘相比，未标记抗B1住院患者 在对照组中， 随机试验本研究在以下患者中进行： 化疗难治性（多柔比星耐药或烷化剂耐药） 低年级NHL谁已经完成后一年内完成， 末次化疗方案。首先接受131 I-抗B1治疗的患者 接受未标记抗B1输注，然后立即 输注抗B1（已用5 mCi 131 I进行痕量标记）。 由示踪剂剂量传递到全身的辐射剂量超过 根据放射性清除率计算约1周 数据根据这些针对每个人的计算 患者，给予131 I-抗B1的RIT剂量， 递送75 cGy的辐射剂量。在未标记的抗体臂中， 患者将接受等量的未标记B1。部分 患者可能单向交叉至抗B1 RIT组 疾病进展后使用未标记的抗B1治疗。 放射性标记抗B1治疗也将允许进行比较 同一患者接受标记和未标记药物治疗后的反应 抗B1抗体两组的反应将在六周后评估， 12周，此后每隔12周一次，直至2年后 最后一名患者的登记。交叉可以发生多达21 在最后一名患者入组后几个月。

This is a multicenter prospectively randomized study between 131 Iodine- Anti-B1 RIT and unlabeled Anti-B1 monoclonal antibody therapy for patients with chemotherapy-refractory low-grade B-cell lymphomas. The objectives of this study are to assess the incremental clinical activity and toxicity of radiolabeling murine monoclonal Anti-CD20 antibody (Anti-B1) with 131 Iodine as compared to unlabeled Anti-B1 inpatients with relapsed low-grade non-Hodgkin's lymphome (NHL) in a controlled and randomized trial. This study is being conducted in patients with chemotherapy-refractory (doxorubicin-resistant or alkylator-resistant) low-grade NHL who have progessed within one year after completing the last chemotherapy regimen. Patients treated with 131 I-Anti-B1 first receive an infusion of unlabeled Anti-B1 immediately followed by an infusion of Anti-B1 which has been trace lableled with 5 mCi of 131I. The radiation dose to the whole body delivered by the tracer dose over approximately one week is calculated from the radioactivity clearance data. Based upon these calculations specific for each individual patient, a RIT dose of 131 I-Anti-B1 is given so that a whole body radiation does of 75 cGy is delivered. In the unlabeled antibody arm, patients will receive an equivalent amount of unlabeled B1. Partial one-way crossover to the Anti-B1 RIT arm will be possible for patients treated with unlabeled Anti-B1 following progression of the disease. This treatment with radiolabeled Anti-B1 will also allow for comparison of responses in the same patient treated with both labeled and unlabeled Anti-B1. Response in both arms will be assessed after six weeks, after 12 weeks and in 12 weekly intervals thereafter up to two years following enrollment of the last patient. Crossover can take place up to 21 months following the enrollment of the last patient.