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.

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