PROTOCOL G2002-09: A PHASE II STUDY TO EVALUATE THE SAFETY AND EFFICACY

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。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。所列机构为中心，不一定是研究者所在机构。这是一项II期、开放标签研究，在Genitope研究2000-03中登记的初始化疗失败或在化疗后26周休息期内进展并因此有资格随机分配至研究免疫部分的患者将接受Rituxan，并有机会接受患者特异性Id-KLH免疫治疗。 根据Genitope研究2000-03方案，患者必须完成8个周期的环磷酰胺、阿替斯汀和泼尼松（CVP）治疗，并进行中心影像学审查，确认其未能达到或维持完全缓解（CR）、CRu或部分缓解（PR），因此无资格继续随机分配至Genitope研究2000-03的免疫接种部分。

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. This is a Phase II, open-label study in which patients registered on the Genitope study 2000-03 who have either failed initial chemotherapy or progressed during a 26-week rest period following chemotherapy and are thereby eligible for randomization to the immunization portion of the study will receive Rituxan and have an opportunity to receive patient-specific Id-KLH immunotherapy. Patients must have completed 8 cycles of Cyclophosphamide, Vincristin, and Prednisone (CVP) per the Genitope study 2000-03 protocol, and have had a central radiographic review confirming that they failed to achieve or maintain a complete response (CR), CRu or partial response (PR) and were thereby ineligible to proceed with randomization to the immunization portion of the Genitope study 2000-03.