KLH WITH GM-CSF, IN PATIENTS WITH FOLLICULAR NON-HODGKIN'S LYMPHOMA

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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.