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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。鉴于抗CD20抗体在治疗滤泡性低级别淋巴瘤（通过靶向CD20细胞表面抗原）中的有效性，我们假设该抗体在治疗惰性、CD20阳性淋巴细胞为主的霍奇金病（LPHD）中也会显示出同样的有效性。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13例患者（大约每月2-3例）。如果在3/13例患者中证明有反应，则研究将继续进行，直到达到43例患者。患者将经常随访反应和反应持续时间，直到疾病进展或治疗后两年。入组后2周内，患者将开始治疗。每例患者接受抗cd20抗体375 mg/m2静脉滴注，作为门诊患者每周给予x 4次治疗。终点：本研究的主要终点是评估未经治疗和复发性LPHD对使用利妥昔单抗（anti-CD20, Rituxan）的完全缓解率。次要终点将是测量无疾病和无进展的时间间隔。分析方法：通过CT扫描进行疾病测量，使用东部肿瘤合作组织（ECOG）毒性标准测量毒性。临床反应将由测量的代表性肿瘤病变的二维积之和的减少来定义。正面回应包括部分回应（PR）或完整回应（CR）。确定完全缓解将作为疗效的主要标准。反应持续时间和无病生存期也将作为疗效的单独标准进行测量。部分反应也将作为疗效的次要终点进行测量。此外，也将测量无进展生存期。所有接受至少一剂药物治疗的受试者将被评估临床安全性和耐受性。治疗期包括从第一次注射抗体到最后一次注射抗体后的6个月。

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.