CLINICAL TRIAL: KLH WITH GM-CSF, IN PATIENTS WITH FOLLICULAR NON-HODGKIN'S LYMPH

临床试验：KLH 联合 GM-CSF，用于滤泡性非霍奇金淋巴瘤患者

• 批准号: 7717852
• 负责人: Ronald Levy
• 金额: $ 0.05万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717852
• 关键词: Adverse effects; Biological; Carrier Proteins; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Disease remission; Double-Blind Method; Erythema; Follicular Lymphoma; Funding; Grant; Hodgkin Disease; Immunoglobulin Idiotypes; Immunotherapy; Induration; Injection of therapeutic agent; Institution; Keyhole Limpet Hemocyanin; Lymph; Molecular; Pain; Patients; Personal Satisfaction; Phase; Phase III Clinical Trials; Protein Binding; Randomized; Recombinants; Reporting; Research; Research Personnel; Resources; Safety; Site; Source; Techniques; United States National Institutes of Health; Vaccines

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 randomized, double-blind, Phase III study to evaluate the safety and efficacy of this specific immunotherapy, compared to non-specific immunotherapy in patients with follicular non-Hodgkin's Lymphoma (NHL). Genitope, the study sponsor, relies on recombinant molecular biological techniques to produce the idiotype vaccine. The study will determine if GTOP-99 (the compound of idiotype protein bound to the carrier protein KLH is know as GTOP-99) has efficacy in prolonging remission. Observations of the side effects have been consistent with relevant Phase II vaccine studies. The vaccines have been well tolerated, with erythema, induration, and mild pain at the injection sites, the most commonly reported side effects.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 这是一项随机、双盲 III 期研究，旨在评估这种特异性免疫疗法与非特异性免疫疗法在滤泡性非霍奇金淋巴瘤 (NHL) 患者中的安全性和有效性。 研究发起人 Genitope 依靠重组分子生物学技术来生产独特型疫苗。 该研究将确定GTOP-99（与载体蛋白KLH结合的独特型蛋白的化合物，称为GTOP-99）是否具有延长缓解期的功效。 对副作用的观察与相关的二期疫苗研究一致。 疫苗的耐受性良好，最常见的副作用是注射部位出现红斑、硬结和轻微疼痛。