EFFICACY OF ANTI-CD20 ANTIBODY IN LYMPHOCYTE PREDOMINANT HODGKIN'S DISEASE

抗 CD20 抗体在淋巴细胞为主型霍奇金病中的疗效

基本信息

批准号：
7605162
负责人：
SANDRA J. HORNING
金额：
$ 2.11万
依托单位：
STANFORD UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-02-15 至 2007-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7605162
关键词：
Antibodies Clinical 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

项目摘要

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.

该子项目是利用该技术的众多研究子项目之一资源由 NIH/NCRR 资助的中心拨款提供。子项目和研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金，因此可以在其他 CRISP 条目中表示。列出的机构是对于中心来说，它不一定是研究者的机构。鉴于抗 CD20 抗体在治疗滤泡性低度淋巴瘤（通过靶向 CD20 细胞表面抗原）方面的有效性，我们假设该抗体在治疗惰性 CD20 阳性淋巴细胞为主型霍奇金病方面将显示出相同的有效性。 LPHD）。实验设计：这是一项单臂、前瞻性、两阶段、II 期试验。第一阶段需要招募 13 名患者（大约每月 2-3 名）。如果 3/13 名患者得到缓解，研究将继续进行，直至达到 43 名患者。将定期跟踪患者的反应和反应持续时间，直到疾病进展或治疗后两年。入组后两周内，患者将开始治疗。每位患者每周门诊接受抗CD20抗体375 mg/m2静脉输注×4次治疗。端点：本研究的主要终点是评估未治疗和复发性 LPHD 对使用利妥昔单抗（抗 CD20，Rituxan）的完全缓解率。次要终点是测量无病间隔和无进展间隔。分析方法：将通过 CT 扫描进行放射学测量，并使用东部肿瘤合作组 (ECOG) 毒性标准测量毒性。临床反应将通过测量的代表性肿瘤病变的二维乘积之和的减少来定义。积极响应将包括部分响应 (PR) 或完整响应 (CR)。确认的完全缓解将被确定为疗效的主要标准。反应持续时间和无病生存期也将作为单独的疗效标准进行测量。部分反应也将作为疗效的次要终点进行测量。此外，还将测量无进展生存期。所有接受至少一剂药物的受试者都将接受临床安全性和耐受性评估。治疗期包括从第一次注射抗体到最后一次注射抗体后六个月的时间。