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

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 考虑到抗CD 20抗体在治疗滤泡性低度淋巴瘤（通过靶向CD 20细胞表面抗原）中的有效性，我们假设该抗体在治疗惰性、CD 20阳性淋巴细胞主导型霍奇金病（LPHD）中将显示出相同的有效性。 实验设计： 这是一项单组、前瞻性、两阶段、II期试验。第一阶段将需要13名患者（大约每月2-3名）。如果在3/13例患者中证实缓解，则研究将继续进行，直至达到43例患者的招募。将定期随访患者的缓解和缓解持续时间，直至疾病进展或治疗后2年。 入组后2周内，患者将开始治疗。每例患者将作为门诊患者接受抗CD 20抗体375 mg/m2静脉输注，每周一次，共4次治疗。 结束点： 本研究的主要终点是评价未治疗和复发性LPHD对使用利妥昔单抗（抗CD 20，Rituxan）的完全缓解率。次要终点将是测量无疾病和无进展间期。 分析方法： 将通过CT扫描进行放射学测量，并使用东部肿瘤协作组（ECOG）毒性标准测量毒性。临床缓解将通过测量的代表性肿瘤病变的二维乘积总和的减少来定义。阳性缓解包括部分缓解（PR）或完全缓解（CR）。确认的完全缓解将被确定为疗效的主要标准。缓解持续时间和无病生存期也将作为疗效的单独标准进行测量。 部分缓解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。将评估所有接受至少一剂药物的受试者的临床安全性和耐受性。治疗期将包括从首次抗体给药至末次抗体给药后6个月的时间。

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.