ANTI C20 IDEC C2B8 (RITUXIMAB) IN AIDS ASSOCIATED NON HODGKINS LYMPHOMA

抗 C20 IDEC C2B8（利妥昔单抗）治疗艾滋病相关非霍奇金淋巴瘤

• 批准号: 6263448
• 负责人: MANSOOR N SALEH
• 金额: $ 2.95万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6263448
• 关键词: AIDS related neoplasm /cancer; AIDS therapy; antineoplastics; clinical research; drug screening /evaluation; human subject; human therapy evaluation; neoplasm /cancer chemotherapy; nonHodgkin's lymphoma; virus load

The purpose of this study is to determine the tolerance and toxicity of single agent Rituximab in patients with AIDS-associated NHL and the effect of Rituximab on the peripheral blood lymphocytic subsets and HIV viral load in patients with AIDS-associated NHL. Patients who have met the inclusion and exclusion criteria and have completed the pretreatment evaluation will receive Rituximab administered intravenously weekly. Each course will be given at the GCRC with observation for 24 hours after completion of drug administration. Initial enrollment will be limited to three patients. All three initial patients will be observed for at least two weeks following the last antibody infusion. If no more than one patient experiences dose-limiting toxicity, the remaining three patients will be enrolled. If at any time two patients have experienced dose-limiting toxicity, no further enrollment will proceed.

本研究的目的是确定单药利妥昔单抗在艾滋病相关非霍奇金淋巴瘤患者中的耐受性和毒性，以及利妥昔单抗对艾滋病相关非霍奇金淋巴瘤患者外周血淋巴细胞亚群和HIV病毒载量的影响。符合纳入和排除标准并完成预处理评估的患者将接受每周静脉注射利妥昔单抗。每个疗程将在GCRC进行，并在给药完成后观察24小时。初始登记将限制为3名患者。在最后一次抗体输注后，所有三名初始患者将被观察至少两周。如果没有超过一名患者出现剂量限制性毒性，则其余三名患者将入组。如果在任何时候有两名患者出现剂量限制性毒性，则不再进行进一步的入组。