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，研究对象为131碘- 抗B1RIT与未标记抗B1McAb联合治疗 化疗难治的低度B细胞淋巴瘤患者。这个 本研究的目标是评估递增的临床活动 放射性标记小鼠抗CD20单抗的毒性研究 131碘(抗-B1)与未标记抗-B1住院患者的比较 复发的低级别非霍奇金淋巴瘤(NHL) 随机试验。这项研究正在对患有以下疾病的患者进行 化疗难治(耐阿霉素或抗烷化剂) 完成治疗后一年内进展的低级别NHL 最后的化疗方案。先用131I-抗-B1治疗的患者 立即输注未标记的抗-B1，之后立即注射 用5mCI~(131)I示踪的抗-B1的输注。 示踪剂剂量超标对全身的辐射剂量 大约一周是从放射性清除计算出来的 数据。根据这些针对每个人的计算 病人，给予131I-抗-B1的RIT剂量，以便全身 辐射剂量为75cGy.在未标记的抗体臂中， 患者将接受等量的未标记B1。部分 患者可以单向交叉到抗B1RIT臂 随着疾病的进展，使用未标记的抗-B1治疗。 这种用放射性标记的抗B1抗体的治疗也将允许进行比较 在同一患者中同时使用标记和非标记治疗的反应 抗B1抗体。双方的反应将在六周后进行评估， 12周，此后每隔12周至两年 最后一位病人的登记。交叉最多可进行21次 最后一位患者登记后的几个月。

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.