VACCINATION WITH CONJUGATED FOLLICULAR LYMPHOMA-DERIVED IDIOTYPE PLUS GM-CSF

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。在这项nci赞助的III期随机试验中，患者必须患有III/IV期滤泡性淋巴瘤。他们必须有2厘米的淋巴结，以便切除和收获淋巴瘤，以生产自体疫苗。所有患者将接受标准化疗（PACE）。如果患者获得PACE的临床反应，他们将被随机分配接受KLH疫苗（第1天）+ GM-CSF（第1-4天）或KLH对照疫苗（第1天）+ GM-CSF（第1-4天）。因此，研究人员将确定与KLH结合的自体滤泡性淋巴瘤衍生免疫球蛋白的免疫效果，并将其与单独的KLH进行比较，以诱导和维持临床完全缓解的能力，并消除亚临床残留肿瘤细胞，如PCR检测到的，在该肿瘤的标准初始治疗后。临床前和临床非随机数据支持本研究的设计。将为每位患者制作单独的自体疫苗。低剂量GMCSF将作为辅助治疗。疫苗将由NCI生产。PACE化疗后至少6个月开始免疫接种。将在6个月内进行5次免疫接种（1、2、3、4、6个月注射）。

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. In this NCI-sponsored phase III randomized trial, patients must have stage III/IV follicular lymphoma. They must have lymph nodes 2 cm for resection and harvest of lymphoma for the production of an autologous vaccine. All patients will receive the standard chemotherapy (PACE). If patients attain a clinical response with PACE they will be randomized to receive either KLH vaccine (day 1) + GM-CSF (days 1-4) or KLH control vaccine (day 1) + GM-CSF (days 1-4). Thus, the investigators will determine the effects of immunization with autologous, follicular lymphoma-derived immunoglobulin conjugated to KLH as compared with KLH alone on the ability to induce and sustain clinical complete remission and to eliminate subclinical residual tumor cells, as detected by PCR, following standard initial therapy for this tumor. Preclinical and clinical nonrandomized data support the design of this study. A separate autologous vaccine will be made for each patient. Low-dose GMCSF will be used as adjuvant therapy. The vaccines will be made by the NCI. Immunizations start at least six months after PACE chemotherapy. Five immunizations will be done over 6 months (1, 2, 3, 4, 6 month injections).