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

结合滤泡性淋巴瘤衍生独特型加 GM-CSF 疫苗接种

• 批准号: 7378272
• 负责人: FRANCO MUGGIA
• 金额: $ 0.28万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378272
• 关键词: VACCINATION; CONJUGATED; FOLLICULAR; LYMPHOMA; DERIVED

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).

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中出现。列出的机构是中心的机构，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，用于切除和收集淋巴瘤以生产自体疫苗。所有患者都将接受标准化疗（PACE）。如果患者通过 PACE 获得临床缓解，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，研究人员将确定与单独的 KLH 相比，用与 KLH 缀合的自体滤泡性淋巴瘤衍生免疫球蛋白进行免疫对诱导和维持临床完全缓解以及消除亚临床残留肿瘤细胞的能力的影响（如 PCR 检测），如下该肿瘤的标准初始治疗。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将用作辅助治疗。这些疫苗将由国家癌症研究所生产。 PACE 化疗后至少六个月开始免疫接种。将在 6 个月内进行五次免疫接种（1、2、3、4、6 个月注射）。