CLINICAL TRIAL: EVALUATE THE EFFICACY OF ANTI-CD20 ANTIBODY IN LYMPHOCYTE PREDOM

临床试验：评估抗 CD20 抗体在前淋巴细胞中的功效

• 批准号: 7717845
• 负责人: SANDRA J. HORNING
• 金额: $ 0.36万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717845
• 关键词: Antibodies; Clinical; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Disease; Disease Progression; Disease-Free Survival; Dose; Eastern Cooperative Oncology Group; Effectiveness; End Point; Enrollment; Evaluation; Experimental Designs; Funding; Grant; Hodgkin Disease; In complete remission; Indolent; Institution; Lesion; Lymphocyte; Lymphoma; MS4A1 gene; Measurement; Measures; Outpatients; Patients; Pharmaceutical Preparations; Phase; Phase II Clinical Trials; Progression-Free Survivals; Rate; Recurrence; Research; Research Personnel; Resources; Roche brand of rituximab; Safety; Source; Staging; Sum; Surface Antigens; Time; Toxic effect; United States National Institutes of Health; Upper arm; Week; X-Ray Computed Tomography; analytical method; intravenous administration; partial response; prospective; response; rituximab; tositumomab; treatment duration; tumor

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Given the effectiveness of an anti-CD20 antibody in treating follicular low-grade lymphoma (by targeting the CD20 cell surface antigen), we hypothesize that this antibody will show equal effectiveness in the treatment of indolent, CD20-positive Lymphocyte-Predominant Hodgkin's Disease (LPHD). Experimental Design: This is a single-arm, prospective, two-stage, phase II trial. Accrual of 13 patients (at an approximate rate of 2-3 per month) will be necessary for the first phase. If response is demonstrated in 3/13 patients, the study will continue until an accrual of 43 patients is reached. Patients will be followed at frequent intervals for response and duration of response, until disease progression or two years post-treatment. Within 2 weeks of enrollment, the patients will start therapy. Each patient will receive anti-CD20 antibody 375 mg/m2 intravenous infusion given as an outpatient every week x 4 treatments. Endpoints: The primary endpoint of this study is an evaluation of the complete response rate of untreated and recurrent LPHD in response to the use of Rituximab (anti-CD20, Rituxan). Secondary endpoints will be to measure disease-free and progression-free intervals. Analytical Methods: Disease measurements will be made radiographically by CT scan, and toxicities will be measured using the Eastern Cooperative Oncology Group (ECOG) toxicity criteria. Clinical response will be defined by reduction in the sum of the bidimensional products of measured representative tumor lesions. Positive responses will include Partial Responses (PR) or Complete Responses (CR). Confirmed complete responses will be determined as a primary criteria for efficacy. Duration of response and disease-free survival will also be measured as separate criteria for efficacy. Partial responses will also be measured as a secondary endpoint for efficacy. Additionally, progression free survival will also be measured. All subjects who receive at least one dose of medication will be assessed for clinical safety and tolerability. The treatment period will include the time from the first dose of antibody to six months following the last dose of antibody.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 鉴于抗CD20抗体在治疗卵泡低度淋巴瘤中的有效性（通过靶向CD20细胞表面抗原），我们假设该抗体将在治疗懒惰的，CD20阳性淋巴细胞淋巴细胞前活体的霍奇金病（LPHD）方面表现出同等的有效性。 实验设计： 这是一项单臂前瞻性，两阶段的II期试验。第一阶段需要13例患者的应计（每月约为2-3个）。如果在3/13例患者中证明了反应，则该研究将继续进行，直到达到43例患者。患者将经常遵循以应对和反应持续时间，直到疾病进展或治疗后两年。 在入学后的2周内，患者将开始治疗。每位患者每周将接受抗CD20抗体375 mg/m2静脉输注，每周X 4治疗。 端点： 这项研究的主要终点是对使用利妥昔单抗（抗CD20，Rituxan）的未经处理和复发LPHD的完整响应率进行评估。次要终点将是测量无病和无进展的间隔。 分析方法： 疾病测量将通过CT扫描进行射线照相，并使用东部合作肿瘤学组（ECOG）毒性标准来测量毒性。临床反应将通过减少测量代表性肿瘤病变的双度产物的总和减少来定义。积极的响应将包括部分响应（PR）或完整响应（CR）。确认的完整响应将被确定为功效的主要标准。反应持续时间和无病生存期也将作为疗效的独立标准进行衡量。 部分响应也将作为功效的次要终点测量。另外，还将测量无进展生存。所有接受至少一剂药物的受试者均应评估临床安全性和耐受性。治疗期将包括从第一次剂量的抗体到最后剂量抗体后六个月的时间。