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

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 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相比在滤泡性非霍奇金淋巴瘤（NHL）患者中的安全性和有效性。 Genitope是研究的发起者，它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）是否具有延长缓解的功效。 副作用的观察结果与相关的II期疫苗研究一致。 疫苗耐受性良好，注射部位出现红斑、硬结和轻微疼痛，这是最常见的副作用。

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.